Senior Regulatory Affairs Associate-Biologics

Parexel

4-8 years

Preferred by Comapny

Bengaluru

10 Nov. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Regulatory Affairs Associate

Job Description:

We are looking for a Senior Regulatory Affairs Associate with 4-8 years of experience in the pre- and post-approval lifecycle management of drug products, including small molecules and biologics, across various markets. The ideal candidate will have experience in regulatory frameworks and a solid understanding of global pharmaceutical legislation and regulatory CMC (Chemistry, Manufacturing, and Controls) aspects.

This role requires a strong background in EU/US regulatory procedures, with knowledge of ROW (Rest of World)markets being a bonus, and the ability to manage complex regulatory submissions and variations.

Key Responsibilities:

Regulatory Lifecycle Management:
- Manage pre- and post-approval lifecycle for drug products (small molecules and biologics) across global markets.
- Contribute to regulatory submissions, from simpler to more complex submissions, in alignment with global and regional regulatory requirements.
Regulatory Submissions:
- Preparation and review of Marketing Authorization Applications (MAAs) and variations for medicinal products (Orals & Parenterals) in the EU through various procedures like DCP, MRP, and National Procedures.
- Handle documentation for Variation procedures such as Super grouping, Grouping, and Work-sharingto Marketing Authorizations.
- Prepare and submit safety variations to Health Authorities and perform post-approval CMC-related updates.
Regulatory CMC and Compliance:
- Manage CMC-related health authority queries and ensure compliance of DMFs, batch records, specifications, and stability data with regulatory requirements.
- Perform regulatory impact assessments for change proposals and identify the required documentation for EU submissions.
- Liaise with cross-functional teams to ensure compliance with regulatory standards and submission requirements.
Coordination & Stakeholder Management:
- Work closely with internal and external teams to ensure effective submission delivery plans and manage submission content plans.
- Provide regular status updates to stakeholders regarding submission progress.
Regulatory Information Systems:
- Utilize Regulatory Information Management Systems (e.g., Veeva Vault) for efficient tracking and submission of regulatory documents.
Team Mentorship & Communication:
- Provide guidance and mentorship to junior team members.
- Demonstrate strong communication skills in coordinating with internal teams, stakeholders, and Health Authorities.
Regulatory Strategy & Planning:
- Lead or assist in regulatory strategy discussions and contribute to overall product development goals by aligning with regulatory trends and requirements across regions.

Required Skills & Qualifications:

Experience: 4-8 years of relevant experience in regulatory affairs, specifically in the life cycle management of small molecules and biologics.
Regulatory Knowledge: Solid understanding of EU and US regulatory procedures, including post-approval requirements. Knowledge of ROW markets is a plus.
CMC Expertise: Experience handling CMC-related health authority queries, and preparing and reviewing DMFs, batch records, specifications, and stability data.
Documentation & Variations: Proven experience in preparing Marketing Authorization Applications (MAA)and variations (including super grouping and work-sharing procedures).
Information Management: Familiarity with Regulatory Information Management Systems, such as Veeva Vault.
Teamwork & Mentorship: Strong communication and collaboration skills, with the ability to mentor junior staff and work cross-functionally.
Autonomy: Ability to work independently and manage complex regulatory tasks and submissions.

Desired Skills:

Knowledge of global pharmaceutical legislation and ICH regulations related to regulatory CMC aspects.
Experience in regulatory review of complex data (e.g., stability data, batch records, specifications).
Ability to handle and resolve regulatory impact assessments for changes.

This position offers a chance to lead regulatory affairs efforts within a dynamic team, contributing to both the pre-market approval and post-market maintenance of drug products, ensuring their compliance with global regulatory standards.

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Senior Regulatory Affairs Associate-Biologics

Job Description

Job Title: Senior Regulatory Affairs Associate

Job Description:

Key Responsibilities:

Required Skills & Qualifications:

Desired Skills:

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