Regulatory Affairs Associate
New
IndiaFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 2+ years
Requirements
- 2+ years of experience in regulatory affairs within the pharmaceutical or life sciences industry.
- Proven experience with MAAs, variations, renewals, and post-approval lifecycle management.
- Working knowledge of EU regulatory procedures and centralized procedure coordination.
- Familiarity with regulatory documentation including Module 1, CMC, and safety updates.
- Proficiency with regulatory systems such as Veeva Vault, RIMS, or similar platforms.
- Understanding of health authority portals and submission processes.
- Exposure to PSUR preparation, regulatory intelligence, and compliance monitoring.
- Bachelor’s degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, or a related field.
- Strong attention to detail and organizational skills.
- Ability to manage multiple tasks in a deadline-driven environment.
Responsibilities
- Manage regulatory submissions including variations, renewals, MA transfers, withdrawals, and health authority query responses.
- Support preparation and coordination of Module 1 activities covering CMC, safety, administrative updates, and post-approval changes.
- Handle country-specific regulatory requirements and submissions through health authority portals.
- Maintain and update regulatory information using systems such as RIMS and Veeva Vault.
- Support linguistic reviews, translation coordination, readability testing, and artwork/mock-up approvals.
- Assist in promotional material review and product information updates.
- Support PSUR submissions and country-level regulatory intelligence activities.
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