Talent.com
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Biotech HealthcareAhmedabad, Republic Of India, IN
30+ days ago
Job description

Role Objective

Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. The role ensures timely preparation and updating of Technical Master Files, supports product registrations, manages post-market surveillance activities, and contributes to audit readiness. This position requires close collaboration with internal stakeholders to ensure consistent regulatory compliance across the organization.

Desired Candidate Profile

  • Graduate / Postgraduate in Pharmacy, Biotechnology, Life Sciences, or a related discipline.
  • 6–9 years of experience in Regulatory Affairs, preferably in the pharmaceutical, biotechnology, or medical devices industry.
  • Strong understanding of international regulatory guidelines (e.G., EU MDR, US FDA, ISO standards).
  • Demonstrated experience in dossier preparation, technical file management, and compliance documentation.
  • Proficiency in MS Office and regulatory database searches.

Role & Responsibilities

  • Prepare and maintain Technical Master Files (TMFs) for all products, ensuring timely updates and regulatory accuracy.
  • Conduct scheduled reviews of TMFs to ensure consistency and alignment of technical content across product categories.
  • Prepare and update critical technical documents, including Risk Management Reports, Preclinical and Biological Evaluations, and Evaluation Summary Reports (ESRs).
  • Ensure timely preparation and updates of Post-Market Surveillance (PMS) reports, incorporating relevant findings.
  • Perform periodic searches of MAUDE and other relevant country-specific databases;

    • summarize and integratefindings into PMS and Risk Management documentation.

  • Support audit preparations by ensuring completeness, accuracy, and readiness of technical files.
  • Review, compile, and finalize product registration dossiers in line with country-specific regulatory requirements.
  • Collaborate with the Regulatory Affairs team to monitor compliance activities, track file status, and provide daily progress updates.
  • Provide regulatory and documentation support to cross-functional teams in line with organizational priorities.

    • Functional Skills Required

  • In-depth knowledge of regulatory requirements and submission processes across multiple markets.
  • Expertise in the preparation of dossiers, TMFs, PMS, and Risk Management documentation.
  • Strong documentation, review, and editing skills.
  • Familiarity with regulatory intelligence tools and database search methodologies.
  • Ability to prepare audit-ready documentation.

    • Behavioral Skills Required

  • Strong attention to detail with high accuracy.
  • Effective communication and collaboration skills for cross-functional teamwork.
  • Ability to prioritize tasks and manage timelines under pressure.
  • Proactive problem-solving and decision-making skills.
  • Accountability and ownership of assigned deliverables.

    • Team Size to be Handled :

    Individual Contributor role, reporting to the Sr. 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.

    Create a job alert for this search

    Regulatory Specialist • Ahmedabad, Republic Of India, IN