Job Description

Key Responsibilities

:

Regulatory Compliance & Monitoring

: Ensure that the company's products comply with the regulatory requirements of the regions in which they are distributed. Stay current with national and international legislation, guidelines, and customer practices.

Regulatory Submissions & Documentation

: Prepare and submit regulatory dossiers, documents, and samples for participation in tenders, adhering to market-specific requirements. Collect, collate, and evaluate scientific data from various sources, preparing dossiers in CTD/ACTD formats as per market demands.

Product Registration & Approvals

: Monitor timelines for registration, variations, renewal approvals, and submissions to ensure timely completion. Follow up with the marketing team to ensure marketing authorization, registration data, and status are up-to-date.

Labeling & Documentation

: Write clear, accessible product labels and patient information leaflets to comply with regulatory standards.

Strategic & Advisory Role

: Provide strategic regulatory advice to senior management during new product development. Advise country sales managers on regulatory requirements to ensure market compliance.

Team Management & Collaboration

: Lead and manage teams of colleagues involved in the development of new products, ensuring adherence to regulatory processes. Work closely with cross-functional teams, including marketing, legal, and R&D, to ensure compliance.

Regulatory Audits & System Review

: Undertake and manage internal regulatory audits to ensure compliance with internal and external standards. Review company practices and advise on necessary changes to systems and procedures to align with regulatory requirements.

Stakeholder Liaison

: Liaise with regulatory authorities and stakeholders, including making presentations and participating in meetings as needed.

Packaging & Advertising Approvals

: Participate in the development of marketing concepts and approve packaging and advertising materials prior to product release to ensure they comply with regulatory standards.
Job Type: Full-time

Pay: ₹300,000.00 - ₹400,000.00 per year

Benefits:

Paid sick time Paid time off Provident Fund
Work Location: In person