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30/06 HR
Consultant at Domnic Lewis International

Views:173 Applications:6 Rec. Actions:Recruiter Actions:0

Director - International Regulatory Affairs - Pharma (12-20 yrs)

Chennai Job Code: 1281398

Job Description

- Develop and implement innovative regulatory strategies for international markets to ensure rapid approval of products, considering international requirements.

- Communicate and update the International section of the Regulatory Strategy Document for assigned products/projects.

- Deliver regulatory milestones, assessing the probability of regulatory success and implementing risk mitigation measures.

- Assess emerging data, identify project risks, and provide updates to leadership teams.

- Act as the single point of contact and representative for Regional Regulatory Affairs on Regional Product Teams.

- Plan and create the International dossier and contribute to the Global Regulatory Strategy for product(s).

- Engage with regional commercial teams to align regulatory strategies with business needs.

- Represent the company effectively in health authority meetings, ensuring clear documentation of discussions and agreements.

- Provide leadership, coaching, and mentoring to regulatory teams to ensure successful delivery of objectives.

- Lead regulatory activities in product in-license/due diligence reviews, divestments, and withdrawals.

- Contribute to the regulatory community and Regulatory Excellence objectives.

- Monitor changes in the regulatory environment and collaborate with commercial teams to provide guidance and support.

- Collaborate with commercial colleagues to influence guidance within leading Health Authorities.


- Bachelor's degree in a science-related field.

- Previous experience in interacting with major health authorities.

- Extensive knowledge of regulatory drug development and product approval/launch.

- Broad background in pharmaceutical business and experience in various areas of regulatory affairs.

- Leadership and program management experience.

- Strategic thinking and the ability to evaluate risks in complex development programs.

- Successful contribution to a major regulatory approval in the International Region.

- Commercial and cross-cultural awareness, ability to work effectively with colleagues from different regions.

- Competencies: critical thinking, strategic influencing, innovation, initiative, leadership, and excellent written and verbal communication skills.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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