Regional Regulatory Lead (w/m/d)

Overview:
• Start date: ASAP
• Time of contract: 12 months
• Working hours per week: 41
• Location (on site or remote): Hybrid (mostly remote)
• Language requirements: English

Job Description:
• Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries.
• Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements.
• Communicate effectively to ensure that dossiers meet regional and local content and format requirements.
• Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions.
• Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes.
• Collaborate with internal functions (e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs) to enhance connectivity.
• Stay informed about international legislation and guidelines for biological products and related initiatives (e.g., rare diseases, orphan drugs).

Qualifications & Experience:

• A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
• At least 3 years of regulatory experience within the international region, supported by additional pharmaceutical /industry experience.
• Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP and GCP.
• Proficiency in standard regulatory tools : Veeva, DocNet, Trackwise