Regulatory Affairs Executive

2 days ago

Vadodara, India Biotech Healthcare Full time

Role Objective

Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Desired Candidate Profile

- Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
- 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
- Strong understanding of global regulatory guidelines and dossier preparation.
- Detail-oriented, with excellent organizational and analytical skills.
- Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
- Good written and verbal communication skills.

Roles & Responsibilities

- Screen and analyze documents received for product registration requests as per country-specific guidelines.
- Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
- Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
- Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
- Arrange supportive batch-related documents (e.g., DOC, COA) for registration samples.
- Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
- Support the Compliance team by providing updated documents required for technical file preparation.
- Periodically review and update Technical Master Files to ensure consistency across product categories.
- Coordinate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
- Ensure timely preparation and submission of documents related to audit findings.
- Adhere to departmental priorities and provide support for additional tasks as assigned.

Functional Skills Required

- Knowledge of international regulatory requirements and guidelines.
- Expertise in dossier compilation, review, and submission processes.
- Ability to prepare and analyze technical and compliance-related documentation.
- Familiarity with audit documentation and regulatory query management.
- Document management and record-keeping skills.

Behavioral Skills Required

- Strong attention to detail and accuracy.
- Ability to work effectively under pressure and meet strict deadlines.
- Team player with strong collaboration and coordination skills.
- Proactive, adaptable, and willing to take initiative.
- Professional communication and interpersonal skills.

Team Size to be Handled:

Individual contributor role, reporting to the Assistant Manager - RA.

Important Links:

Website: https://biotechhealthcare.com/

LinkedIn: https://www.linkedin.com/company/biotechhealthcare/

Instagram: Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

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