Job Openings
Senior Executive - Regulatory Affairs (Biologics)
About the job Senior Executive - Regulatory Affairs (Biologics)
Job Title: Senior Executive - Regulatory Affairs (Biologics)
Job Location: Gurugram, Haryana, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Location: Gurugram / Mumbai / Vadodara (open for any of these 3)
- Good understanding and exposure of Market extension filing, post approval life cycle management of Biologic products.
- Ability to understand technical aspects of Biologicals products.
- Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). Contribute to preparation and maintenance of submissions from a global perspective.
- Thorough understanding of the regulatory agency’s requirements of various countries for NDAs/BLA’s, including regional trends, for various types of applications and procedures.
- Hands on experience in performing gap analysis for the registration requirements for emerging markets.
- Ability to Review, assessment and establishing & tracking effective change controls.
- Ability to review of Marketing Authorization Applications & Variations for various types of medicinal products for filing in Global Markets.
- Basic understanding in preparation of SOPs and Work Instructions
- Understanding of local and international regulatory guidelines.
- Strong communications skills. Ability to work independently.
- Effective communication and collaboration skills.
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