Regulatory Affairs Expert for Pharmaceutical Compliance
4 weeks ago
Unlocking Global Regulatory Excellence
About the Role
Parexel is seeking an experienced Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with regulatory requirements for biologic products in various markets.
Responsibilities
- Support the compilation, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes) from a global and/or regional perspective.
- Collaborate with cross-functional members to ensure alignment on product responsibilities and execute submission delivery plans.
- Liaise with regulatory agencies and provide input on local requirements based on guidance.
- Maintain knowledge of local and international regulatory guidelines.
- Prepare and review Marketing Authorization Applications & Variations for filing in Regulated, Emerging, and EU markets.
Requirements
- 8-9 years of experience in handling pre and post-approval life cycle management of Biologic products in regulated (EU/US/Canada) and emerging markets.
- Strong understanding of regulatory frameworks, including regional trends, for various types of applications and procedures.
- Experience working with Regulatory Information Management Systems like Veeva Vault.
- Effective communication and collaboration skills.
What We Offer
- An estimated salary range of $120,000 - $150,000 per annum, depending on location and experience.
- A dynamic and supportive work environment.
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