Director - International Regulatory Affairs - Pharmaceuticals

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.

Requirements :

- 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.