Senior Regulatory Affairs Associate-Biologics

4-8 years

Not Disclosed

Hyderabad

10 Sept. 5, 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

Senior Regulatory Affairs Associate

Position Overview:

We are seeking a Senior Regulatory Affairs Associate with 4-8 years of experience in the management of drug product life cycles, including both small molecules and biologics, across various markets. The ideal candidate will have a solid understanding of regulatory frameworks, regional trends, and the requirements for pre- and post-approval submissions.

Key Responsibilities:

Regulatory Submissions:
- Contribute to the preparation and delivery of regulatory maintenance submissions, ranging from simple to increasingly complex, from both global and regional perspectives.
- Author and review documentation for Marketing Authorization Applications (MAAs) and Variations, ensuring compliance with EU procedures such as DCP, MRP, and National Procedures.
- Prepare documentation for various Variation procedures, including Super Grouping, Grouping, and Work-sharing for Marketing Authorizations.
- Manage post-approval CMC-related updates and safety variations, ensuring timely submission to Health Authorities.
Regulatory Framework and Compliance:
- Demonstrate a thorough understanding of regulatory frameworks and trends for small and large molecules across all regions.
- Handle CMC-related health authority queries and ensure compliance with global pharmaceutical legislation and guidance, particularly ICH requirements.
- Review DMFs, batch records, specifications, and stability data to ensure regulatory compliance.
Cross-Functional Collaboration:
- Liaise closely with cross-functional teams to align on product responsibilities and regulatory requirements.
- Provide regulatory impact assessments for change proposals and identify necessary documentation for EU submissions.
- Execute and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.
Regulatory Information Management:
- Utilize Regulatory Information Management Systems, such as Veeva Vault, to manage and track submissions and regulatory activities.
Team Leadership:
- Mentor and guide team members, leveraging strong communication skills to foster collaboration and ensure adherence to regulatory processes.

Qualifications:

Experience: 4-8 years of relevant experience in regulatory affairs, handling both pre- and post-approval life cycle management for drug products (small molecules and biologics).
Knowledge:
- In-depth understanding of EU and US regulatory procedures, including post-approval requirements.
- Familiarity with regulatory frameworks in ROW markets is a plus.
- Expertise in regulatory CMC aspects and global pharmaceutical legislation, particularly within ICH countries.
Skills:
- Proficiency in Regulatory Information Management Systems like Veeva Vault.
- Strong communication and leadership skills, with the ability to mentor and guide team members effectively.
Education: Relevant degree in life sciences or a related field.

This role offers the opportunity to make a significant impact within a dynamic regulatory environment while advancing your career in a supportive and collaborative setting.

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Senior Regulatory Affairs Associate-Biologics

Job Description

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