Informacje o stanowisku

Regulatory Affairs Director (CMC) Warszawa

Join one of the largest pharmaceutical companies worldwide as a Regulatory Affairs Director (CMC) and play a pivotal role in shaping the future of global regulatory strategies for pharmaceutical products. This is an exciting opportunity to lead high-performing teams, drive strategic initiatives, and collaborate with global leaders to ensure compliance, innovation, and excellence throughout the product lifecycle.

What we expect

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 12+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent.
• Proficiency in English (min. C1).
• Successful experience in leading a diverse community of professionals in a global and matrix environment. Seasoned leader, decision maker and constructive challenger.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
• Proven track record and/or deep understanding in developing and implementing successful CMC regulatory lifecycle strategies and seen as an expert on product development and how it is applied to global regulatory strategy.
• Strong attention to detail with high-level verbal and written communication skills.
• Makes decisions based on facts and sound scientific principles.
• Ability to interact with all levels in the organization.
• Communicates cross-functionally and cross-company; presents and defends CMC management-approved regulatory strategy to project teams; recognizes and accounts for global regulatory impact.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
• Experience leading health authority interactions.
• Strong knowledge of global regulatory laws, regulations, guidance and submission routes pertaining to drugs from early development to commercial maturity.
• Good understanding of competitors in the area and what they are doing in early/late development.

What we offer

• Hybrid model of work for flexibility and convenience.
• Company car to support your mobility needs.
• Comprehensive private medical care and life insurance for you and your family.
• A robust company pension plan to secure your future.
• Reimbursement for sports activities and access to well-being programs to promote a healthy lifestyle.
• Annual bonus recognizing your contributions and achievements.
• Beneficial leave policies to support your personal and professional needs.

Employment agency entry number 47

This job offer is intended for people over 18 years of age.

Warszawa - Oferty pracy w okolicznych lokalizacjach