Company: PAREXEL
Location: Bengaluru (Remote)
Industry: Pharma / Healthcare / Clinical Research
Experience Required: 4-6 years
End Date for Applications: 30th October 2024
About Us:
PAREXEL is a leading global biopharmaceutical service provider, committed to supporting the Bio-Tech and Pharmaceutical industries in the development of new drugs and treatments. We offer knowledge-based contract research, medical communications, and consulting services across a wide range of therapeutic areas.
Job Description:
We are seeking a Regulatory Affairs Associate with 4-6 years of experience in managing the pre and post-approval life cycle of Biologic products in both regulated (EU/US/Canada) and emerging markets. The ideal candidate will possess a strong understanding of the regulatory framework and trends across various types of applications and procedures.
Key Responsibilities:
- Manage the compilation, submission, and approval of country-specific submission files, including Marketing Authorization Applications (MAA), Life Cycle Management (LCM), and post-approval changes.
- Prepare and deliver regulatory maintenance submissions, authoring documents as required.
- Support affiliates in updating local requirements based on guidance from regulatory agencies and input from affiliates/distributors.
- Prepare and review Marketing Authorization Applications & Variations for various medicinal products in regulated and emerging markets.
- Collaborate closely with cross-functional teams to align on product responsibilities.
- Execute and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.
- Utilize Regulatory Information Management Systems, such as Veeva Vault, in your work.
- Communicate effectively and work independently while fostering collaboration within the team.
Qualifications:
- 4-6 years of experience in regulatory affairs, specifically with biologics.
- Strong understanding of local and international regulatory guidelines.
- Proven ability to manage multiple projects and deliver high-quality submissions on time.
- Excellent communication and collaboration skills.
- Experience with Regulatory Information Management Systems (Veeva Vault) is preferred.
If you are passionate about regulatory affairs and ready to contribute to the development of innovative biopharmaceutical products, we would love to hear from you!
To Apply: Please submit your resume and a cover letter highlighting your relevant experience.