About the Role:
The Manager, Regulatory Affairs will play a crucial role in overseeing the regulatory submission process, ensuring compliance with US and EU regulations, and managing product life cycle activities.
Responsibilities:
- Responsible for authoring, compilation and submission of dossier in US, EU, Canada, Australia, new registrations and renewals.
- Review of CMC documentation as per country specific requirements viz. product development documents, Validations (analytical method validation, media fills, process validation, hold time studies), DMFs and related product documentation required for filing of registration dossiers in Stringent regulatory authorities.
- Maintenance of Product life cycle tracker / MIS as per respective SOPs.
- Handling of Product life cycle management activities viz. variations, renewals, notification, annual reports, PVG compliance submission.
- To co-ordinate with cross functional team for documentation generation, review, and finalization.
- Revisions, CAPA and interlinked QMS documents related to pre and post approval changes.
- Should have exposure to handle end to end activities for dossier filing for sterile dosage forms like ophthalmic, injectables.
Qualifications:
- Experience - 8 to 10 Years into Regulatory Affairs.
- Mandatory experience into dossier filling for US and EU market.
- Mandatory experience sterile.
Required Skills:
- Strong understanding of regulatory requirements for dossier submissions.
- Experience in handling CMC documentation.
- Proficient in product life cycle management.
Preferred Skills:
- Experience with sterile dosage forms.
- Ability to work collaboratively in a cross-functional team.
Pay range and compensation package:
- Competitive salary based on experience and qualifications.
Equal Opportunity Statement:
- We are an equal opportunity employer and are committed to fostering a diverse and inclusive workplace. We encourage applications from all qualified individuals regardless of race, gender, age, sexual orientation, disability, or any other characteristic protected by law.
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