Consultant at Domnic Lewis International
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Director - International Regulatory Affairs - Pharmaceuticals (15-22 yrs)
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.
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