Our Culture

Fairness, respect and inclusion sit at the core of our name. Our people are our greatest asset, so we are continually investing in our people, process improvement and technology to deliver the very best to our customers. As an organization, we are committed to inclusion, we own our limitations, and we value new and different ideas.

Eight Signs of a Strong Company Culture

Diversity & Inclusion

Meitheal is passionate about inspiring and maintaining diversity and inclusion in the workplace. Companies that embrace people for their talents and character regardless of age, gender identity, race, sexual orientation, physical or mental ability, ethnicity, and perspective are simply better places of business.

More important, creating an environment where everyone from any background can do their best work isn’t just the right thing to do: It is the smart thing to do.

Equal Opportunity

Meitheal provides equal opportunity employment to all employees and applicants for employment.

We further prohibit discrimination and harassment of any type at work without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Our equal opportunity employment policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Community Meitheal

What do today’s employees really look for in a company, and what are the best ways a business gives back? At Meitheal, those are questions we think about often – and strive to answer in the most meaningful ways.

We understand that today’s dedicated professionals in generics, specialty biopharma and women’s fertility desire qualities such as a good match of skills and position; opportunities to further learn and develop; an inspiring, progressive environment; and a culture of inclusion and diversity.

They also truly want to be a part of something greater – something that gives back and sustains. Meitheal shows its commitment to the community through various employee volunteer opportunities, fundraising, and partnerships with local non-profits.

Just a few of our specific community efforts include:

  • Tutors and board members of Tutoring Chicago, which tutors children of the city and Chicago Public Schools
  • Donors and volunteers for the Greater Chicago Food Bank and the Lakeview Pantry
  • Salvation Army Christmas Giving Tree, providing Christmas presents for children in foster care
  • Feed My Starving Children, packing and shipping meals for developing countries
  • Rosemont Operation North Pole, providing a Christmas experience for terminally ill children who are health-compromised and their families
  • Active partnerships with the Direct Relief Agency, donating our drug products throughout the year during times of crisis or need

Our Benefits

We strive to offer a robust benefits program that meets the needs of each of our team members.
Just a few of the many benefits we offer include:

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Extensive Health
Offerings Including
Medical, Dental, Vision

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Paid Time Off (PTO)

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Company Paid
Holidays

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Onsite Gym
Membership

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401K Retirement
Savings Plan

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Annual
Performance-Bonus
Opportunity

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Short- and Long-Term Disability

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Paid Parental
Leave

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Employee Wellness
Resources

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Flexible Work
Arrangements

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Competitive
Wages

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Life and AD&D
Insurance

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Careers

We love to empower the careers of those who are committed, curious, collaborative, and courageous.

At Meitheal, we are united by our mission to provide easy access to fairly priced products. Meaningful work creates a meaningful career. With this, we provide the opportunity to not only improve the quality of life for patients, but for you to grow professionally as well. We embrace the diversity of our employee culture and the contributions that come from this.

By providing insightful guidance and fostering an environment of empowerment and collaboration, we celebrate our successes together. Our award-winning culture and exceptional team give us much to be proud of.

We are growing rapidly, so check back often!

Summary

Associate Director/Director of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to (Bio)Pharma product development, especially biosimilars, preparing and reviewing submissions.  S/he will work closely with cross-functional teams within the Company and across business partners, including development, regulatory, clinical and quality, as well as  senior leadership team to develop regulatory strategies for both projects and portfolios in BioPharma, contributing to the transformation and growth of regulatory team to meet the needs of company's business growth toward biopharmaceuticals.  

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Understand US regulatory guidance’s on biosimilars, track and interpret new guidance’s & new requirements for biosimilars, and assess their impact on the product development, including expertise, timeline and budgeting.

• Represent the regulatory function on cross-functional developmental teams for biosimilars, primarily with Operation, Quality, Legal and Marketing groups. 

• Prepare, review meeting packages and submissions, including BIA, BPD, INDs, BLAs, etc.

• Serve as an interface with other regulatory groups in development, manufacturing, clinical partners, and consulting services.

• Lead preparation and management of meetings with health authorities, such as US FDA, EMA 

• Contribute to the launch readiness and marketing by guiding the project team on the most appropriate regulatory approach from development through approval and provide post market support. 

• Provide due diligence and review documents from global business partners for technical and regulatory compliance.

• Work with Head of Regulatory Affairs department to build up the competence and capacity for biosimilar and biologics.

• Provide training on CMC and regulatory sciences for biologics and biosimilar within RA department and cross-functions. 

• Provide support to CMC and regulatory sciences of complex generics, especially peptide generics.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience Required

Bachelor, Master, or Ph.D. 's degree in life sciences; over 8 years related experience in product development and/or regulatory CMC, with minimum of 3 years in biologics and/or biosimilars. Or equivalent combination of education and experience. Expertise in and experience with Regulatory Affairs of biosimilars are highly preferred.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Essential Duties and Responsibilities include the following. Other duties may be assigned.


• Contribute to regulatory strategy in new projects and portfolios.


• Provide regulatory guidance and advice to partners in development, technology transfer, and manufacturing


• Manage the regulatory aspects of products and projects, including achievement of timelines and deliverables to align with corporate and departmental goals.


• Prepare, and review communication documents & submissions to the agencies, including controlled correspondences, NDAs, ANDAs, BIA, BPD2/3, BLAs, etc.


• Work and address complex and technical issues with solid scientific rationalization.


• Identify and act on issues and risks from a regulatory perspective, especially for complex generics.


• Provide due diligence and review documents from domestic and international partners for technical and regulatory compliance.


• Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines.


• Represent the regulatory function on cross-functional developmental teams primarily with Operation, Quality, Legal, and Marketing groups.


• Track and interpret FDA new guidance's & new requirements, and assess their impact on product development, including expertise, timeline, and budgeting.


• Support business development efforts 


• Track deficiency trends, and develop proactive and/or mitigation measures accordingly


• Provide training on regulatory sciences within RA department and cross-functions.


Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience Required

Master's or Ph.D.'s degree in life sciences; over 6 years related experience in product development and/or regulatory CMC; or equivalent combination of education and experience. Expertise in and experience with complex /combination generics and/or biosimilars are highly preferred.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Our Human Resources Department is the foundational building block of our organization where you will collaborate with a diverse team of thinkers, innovators and doers in the biopharmaceutical industry.

 

From identifying and recruiting highly skilled talent to cultivating and fostering a dynamic culture of inclusion and continuous development, our HR team is people focused and aims to champion an environment where our employees can learn and thrive.

 

We’re looking for a strategic leader who is hands on with a track record of driving innovation through HR processes and creating effective change through strong project management and execution. 

Essential Duties and Responsibilities

What you will do:



  • Develop and implement HR strategies, initiatives and policies aligned with the overall business strategy.
  • Collaborate with senior leadership and key stakeholders to understand business needs and the organization's goals and strategy.
  • Provide support and guidance to HR team, management and other staff when complex, specialized and sensitive questions and issues arise.
  • Oversee employee disciplinary meetings, terminations and investigations.
  • Help nurture a positive working environment for employees.
  • Oversee the performance review process that drives high performance.
  • Coach managers on performance management discussions, employee relations issues, discipline matters, and promotion/termination discussions.
  • Develop and implement learning and development programs for employees to grow professionally and work with leadership and key stakeholders on career pathing for their departments.
  • Work hands on with the HR team on a variety of HR projects and programs.
  • Regularly audit company procedures, practices and documents to identify improvement opportunities or maintain compliance.
  • Maintain cost-effective and market-competitive benefits programs and engage in training and administering employee benefits programs.
  • Research and stay abreast of industry trends and norms concerning benefit packages, HR laws, compensation plans, etc.
  • Maintain compliance with federal, state and local employment laws and regulations, and recommend best practices; reviews policies and practices to maintain compliance.
  • Manage an effective mentoring program through utilization of external/online training and education opportunities to further develop employees and management.
  • Serves as a coach to both people managers and department leaders on employee engagement, performance management, development, skill development, rewards & recognition, employee relations, and leader effectiveness.
  • Partner with senior leadership to develop action plans to break down org silos and provide innovative talent solutions proactively to meet the changing demands of the organization.
  • Manage and resolve employee relations issues through effective and objective investigation processes, ensuring adherence to appropriate employment laws and policies. 
  • Manage payroll and compensation packages through benchmarking analysis, including compensation philosophies and salary bands.
  • Foster a culture of transparency and effective communication throughout the organization, ensuring that HR processes, policies, and decisions are clearly communicated and understood by all stakeholders.


Qualifications

What you need to be successful:


  • 15+ years of progressive HR experience across most/all areas of responsibility 
  • Bachelor’s degree in Human Resources Management, Social Sciences, Organizational Leadership, Business Management, Operations or similar field of study (Master’s degree is a plus).
  • PHR/SPHR certification is desired.
  • Strategic and operational thinking to drive scalable business growth who is hands on and willing to perform the work needed to get the job done.
  • Strong analytical and critical thinking skills; ability to resolve complex, often ambiguous problems.
  • Superior communication skills and ability to present extensive and in-depth plans to leadership and key stakeholders.
  • Self-starter with the ability to manage multiple projects with minimal oversight.
  • Exceptional attention to detail and accuracy.
  • Must be collaborative and team-focused with a high level of organizational, communication and interpersonal skills.
  • Ability to act with integrity and a high degree of confidentiality and discretion.
  • Demonstrated experience working with an HRIS (Paylocity experience is a plus).
  • Proficient in Microsoft Office, Outlook, PowerPoint and Excel.
  • In-depth knowledge of labor law and HR best practices.
  • Previous experience working with a biopharmaceutical company is a plus.


What You’ll Love About our Company:



  • Watching your hard work have a direct impact on the success of the company.
  • Hybrid Work Environment
  • Competitive Pay
  • Medical, dental and vision insurance.
  • 401K Company Match
  • PTO and paid holidays.
  • Company paid wellness resources and fitness programs.
  • Relaxed, casual dress code.



AAP/EEO Statement

We are an Equal Opportunity Employer 

Summary

The Sr. Associate position is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs. The responsibilities for this position include utilizing publishing systems and processes for the preparation of high-quality submission dossiers and ensuring compliance with the FDA regulations and internal policies/procedures. Pharmaceutical experience required. This is a hybris position, our employees come into our beautiful Rosemont office two days per week.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following:

• Supports the implementation of necessary Regulatory publishing systems, including assistance with validations, qualifications, and verifications of the systems.

• Supports the preparation and implementation of Publishing Operations processes and standards.

• Support all pre and post approval submissions.

• In collaboration with the publishing operations lead, publishes high quality submissions and ensures all   components meet eCTD format requirements.

• Development and Implementation of a File Transfer system, FTP Server.

• Performance of high-level formatting in both word and PDF files, including creating bookmarks, hyperlinks, file optimization, optical character recognition, etc.

• Reviews submissions for compliance with technical requirements.

• Submits eCTD submissions through the ESG FDA gateway.

• Inputs information about submissions into internal databases/systems per internal requirements and procedures.

• Develops and maintains understanding of relevant regulatory requirements for US submissions.

• Timely and effectively supports and troubleshoots the Electronic Submission System.

·  Mentor publishing associates and team members as required.


·  Presents work to various internal and cross-functional teams.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Assimilate to changing environments.

• Ability to prioritize and multitask.

• Be organized and detailed orientated.

• Have a sense of urgency to meet all required deadlines.

Education and/or Experience Required

• Bachelor's degree in life sciences/IT from a 4-year college or university with some experience and/or training in computer systems; or equivalent combination of education and experience.

·                    3+ years’ experience in a pharmaceutical Publishing Associate capacity. 

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Sr. Associate of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) position is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. Ensures effective communication with all the key departments within Meitheal and global Regulatory Affairs in support of regulatory filings.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.


• Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while being in compliance with all regulatory requirements.


• Preparation and review of US FDA submissions, including original NDAs and ANDAs, and amendments, supplements, annual reports, labeling changes to NDAs and ANDAs.


• Reviews documentation from partners both domestic and international for technical and regulatory compliance.


• Represents the Regulatory Affairs department in project development meetings and assists in the development of regulatory strategies.


• Provides regulatory assessments to the company (internal and partners) and implements change controls and/or document changes based on ICH and FDA guidelines.      

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



• Assimilate to changing environments.


• Ability to prioritize and multitask.


• Organized and detailed orientated.


• Have a sense of urgency to meet all required deadlines.

Education and/or Experience Required

• Bachelor's degree in life sciences from a 4-year college or university; a minimum of 2 years related experience and/or training; or equivalent combination of education and experience.


• Experience in Pharmaceutical R&D and/or Manufacturing setting with some exposure to Regulatory Affairs is highly preferred.


• Strong written and communication skills.


• Experience communicating with global teams is preferred.    


• Ability to handle multiple projects concurrently.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

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