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Manager- Regulatory Affair

Manager- Regulatory Affair

Lupin

7 - 12 years

14 - 16 Lacs

Pune

Posted:1 week ago| Platform:

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Skills Required

Biotechnology Team management Pharmacy query product life cycle Process excellence CMC Veterinary Stakeholder management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements.
Preparation of CMC sections, compilation and review of dossiers as per country specific requirements.
Track collection of all dossier/information from all concerned departments and ensure submission to regulatory authorities as per the agreed timeframe.
Responsible for regulatory impact assessment in QAMS (Lupin biotech, Ghotawade facility).
Responsible for preparation and compilation of query responses by coordinating with inter-function teams and submit to regulatory authorities within stipulated timeline.
Continually track any changes, variations or process modifications throughout product life cycle and carry out necessary update to documentation in order to comply with all norms.
Co-ordinate with respective business partners for various regulatory activities throughout the product life-cycle.

Work Experience

7-12 Years of Relevant experience. With team management experience.

Education

Doctorate in Biotechnology or Pharmacy

Masters in Veterinary Science or Biopharmaceutics

Competencies

1. Strategic Agility

3. Customer Centricity

4. Developing Talent

5. Result Orientation

6. Process Excellence

8. Stakeholder Management

7. Collaboration

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