Careers

Summary

The Director of Regulatory Affairs, Global Lead (Biosimilars) is a role vital in supporting Meitheal Specialty Pharma biosimilars division and its biosimilars portfolio collaboration with Xentria, Inc. by assessing planned commercial strategies per product and developing/implementing appropriate global and regional regulatory strategies to secure and maintain market approval according to clinical development and therapeutic area. This role serves as the primary regulatory interface with the project teams and clinical/regulatory CROs. The ideal candidate has professional and scientifically sound experience, excellent communication skills with Regulatory Agencies and the ability to work with cross-functional teams.

Essential Duties and Responsibilities

• Ensures alignment of global regulatory strategies with Sr. Management.
• Leads preparation of global, ex-US regulatory product strategies for assigned products.
• Ensures compliance with global regulatory requirements for biosimilars.
• Key internal leader and driver of regulatory strategy for assigned products.
• Drives and/or contributes to collective development of global/regional regulatory dossiers per eCTD and regulations.
• Ensures alignment of global regulatory strategies with all key stakeholders.
• Develops and implements regulatory acceleration strategies based on data and corporate goals.
• Leads project team in the preparation and maintenance of regulatory risk assessment and mitigation strategy development for assigned products.
• Advises key stakeholders of the effect of current or proposed laws, regulations, updated guidelines and standards related to biologics and biosimilars.
• Manages all interactions with regulatory agencies and acts as company liaison.
• Expands therapeutic area knowledge for team and provides coaching and mentoring to project team members.
• Advises internal project teams regarding proposed commercial strategies specifically regarding regulatory requirements.
• Develops regulatory budget according to product development plans and keeps key stakeholders informed on project resourcing.
• Other duties may be assigned.

Supervisory Responsibilities

None currently.

Competencies

• Clear understanding of Biosimilar Drug Development process from Discovery to Registration/Approval.
• Demonstrated Global Regulatory Affairs experience specifically with LATAM (ANVISA) and/or EMA and/or SFDA submission requirements.
• A high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.

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.

• Demonstrated experience in biosimilar regulatory affairs.
• Detail focused with exceptional organizational skills. 
• Proven ability to show initiative and sense of urgency.
• Proven ability to contribute to project budget and timeline development.

Education and/or Experience Required

• 10 years minimum pharmaceutical industry experience preferred in Regulatory Affairs and/or strategy and dossier development.
• Bachelor of Science in life sciences (pharmacy, biology, chemistry, pharmacology)
• Post graduate degree preferred in related area.
• RAC is strongly preferred.

Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit. The employee is occasionally required to stand; walk and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment

The noise level in the work environment is usually moderate. Travel is anticipated; must be able to manage up to 50% time traveling to Regulatory Agencies and professional meetings.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Pharmacovigilance & Product Complaint Specialist (PV & PC Specialist) position’s primary responsibility is to lead the pharmacovigilance and product complaint activities at Meitheal. The position will be responsible for managing, monitoring, and ensuring compliance with pharmacovigilance operations, including but not limited to, procedures, surveillance, and key performance metrics. The position will oversee the quality of work performed by contract service providers responsible for pharmacovigilance services. The position will lead the product complaint program, including but not limited to, initiation of complaints, complaint investigation reviews, and interactions with customers. The position will assist with the generation and management of Agreements with partners and suppliers. The position will assist with the preparation of quarterly Quality management review presentations related to pharmacovigilance and complaints.

Essential Duties and Responsibilities

Pharmacovigilance Program

• Leads coordination/execution of the pharmacovigilance program with contract service providers responsible for pharmacovigilance services.
• Reviews case processing of safety information.
• Works with Regulatory to submit adverse events to the FDA within applicable timelines.
• Reviews and complete Periodic Adverse Drug Experience Reports to submit to FDA within applicable timelines.
• Adds new products and services in coordination with the contract service providers.
• Supports the conduct of audits and inspections involving pharmacovigilance activities.
• Compiles and present adverse event metrics to Management.
• Generates and review Pharmacovigilance agreements with Partners.
• Ensures procedures and program meet regulatory requirements and standards.

 Product Complaint Program

• Leads coordination/execution with contract service providers responsible for the intake of product complaints and medical inquiries.
• Initiates product complaints within TrackWise Digital system.
• Provides responses to medical inquiries.
• Works with Partners to initiate and review complaint investigations for adequate root cause analysis and appropriate implementation of corrective actions.
• Monitors complaint metrics for trends and ensure high risk/systemic issues are identified and escalated accordingly.
• Ensures complaints are completed within timelines and investigation outcomes are reported to customers.
• Assists in the coordination of Field Alerts, Recalls and Regulatory Agency inspections, as necessary.

Supports management during external inspections.

Remains current in regulatory trends and requirements.

Other duties may be assigned.

Supervisory Responsibilities

None currently.

Competencies

• Code of Federal Regulations and cGMP’s
• Strong written and oral communications skills
• Planning and Organizing
• Interpersonal
• Teamwork
• Project Management
• Problem Solving
• Quality Management
• Judgement
• Dependability
• Ethics

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’s in science or equivalent degree. 3-5 years’ experience in Quality and/or Regulatory with pharmaceutical company or similarly regulated industry.
• Background in aseptic processing and experience working in a cGMP production environment, preferably with injectables.
• Knowledge and understanding of pharmacovigilance regulatory requirements are desired.
• In depth knowledge of cGMP.
• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
• Strong interpersonal skills and great attention to detail are necessary.
• Experience interfacing with FDA during regulatory inspections is a plus.
• Must be a strong team player with good problem solving and good verbal and written communication skills.
• Must be able to handle multiple projects concurrently.

Computer Skills

• Microsoft Word, PowerPoint, Excel,
• TrackWise Digital preferred but not required 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee may have to sit for prolonged periods, stand and walk occasionally while in office and stand and walk frequently during on site audits. The employee is frequently required to talk or hear. The employee may have to occasionally lift and/or move up to 25 pounds.  

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Biosimilar Project Management drives the scientifically advanced development, high-quality manufacturing processes, and complex clinical studies required to obtain FDA approvals to supply biosimilars across Meitheal’s biosimilars portfolio. This role provides program direction and manages timelines and project controls across global functional teams, manufacturing/development sites and external service providers. The ideal candidate possesses strong and effective global project management, problem solving, and interpersonal skills and has a proven track record working cross-functionally across a wide variety of technical, business, and operational areas.

Essential Duties and Responsibilities

• Independently leads and manages cross-functional teams to develop strategies and project plans, including technical, regulatory, and clinical trials and ensure timely completion of new biosimilars projects in alignment with corporate goals.
• In cooperation with the global project team, defines project objectives, requirements, and assumptions necessary to structure a project or task related to biosimilars product development, clinical trials, manufacturing and FDA submission/approval.
• Closely monitors/controls project progression to ensure project is completed on schedule and within budget.
• Reports project progress to all key stakeholders.
• Supports the project team to evaluate project challenges with necessary risk assessment, evaluates budget and timeline impact and implements corrective and/or mitigation.
• Prepares and manages project budget and milestones.
• Cultivates effective communication, cooperation, and trust within the global cross-functional and external teams
• Facilitate and lead effective project meetings.
• Other duties may be assigned.

Competencies

• Understanding of biosimilar CMC development, manufacturing, clinical trials and regulatory areas.
• Experience in planning and managing the global cross functional aspects of biosimilar product development.
• Demonstrated knowledge and application of Project Management tools, such as Risk Management.
• A high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.

Supervisory Responsibilities

None.

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.

• Demonstrated experience in biosimilar project management or related field.
• Detail focused with exceptional organizational skills. 
• Proven ability to show initiative and sense of urgency.

Education and/or Experience Required

• Minimum of 5 years of relevant pharmaceutical or biotech industry experience in biosimilar development and/or biosimilar project management.
• BS Degree or equivalent experience in a related field.

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint).

Physical Demands

While performing the duties of this job, the employee is regularly required to sit. The employee is occasionally required to stand; walk and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.