Overview:
Genmab is seeking a Team Lead / Associate Director to join and help lead its Regulatory Affairs CMC team. This hybrid role combines leadership of a sub-team with hands-on regulatory project work to support the development and lifecycle management of biological products. You’ll contribute to both strategic oversight and operational execution, in a fast-paced, collaborative, and science-driven environment.
Key Responsibilities:
- Lead, mentor, and develop a sub-team within the RA CMC group.
- Provide strategic direction on global regulatory CMC strategies for biologics across all development stages.
- Oversee and contribute to the preparation of regulatory CMC documentation (clinical, marketing, post-approval).
- Guide team members through regulatory decision-making and challenges.
- Act as a liaison with global health authorities and represent Genmab in regulatory interactions.
- Collaborate cross-functionally with CMC and development teams.
- Stay updated on global regulatory requirements and industry best practices.
Qualifications:
- Master’s degree in Pharmacy, Engineering, or related field.
- 10+ years of experience in Regulatory Affairs CMC, with a strong focus on biologics.
- Demonstrated leadership experience (team management or mentorship).
- Experience across the product lifecycle—from early development to post-approval.
- Strong understanding of EU, US, and global regulatory requirements.
- Excellent written and verbal communication skills in English.
Preferred Attributes:
- Strong leadership and team-building skills.
- Collaborative, adaptable, and comfortable with decision-making.
- Passionate about innovation, patient impact, and scientific rigor.
- Experience in fast-paced, cross-functional, global environments.
- Quality- and results-oriented mindset.
Job sourced from Genmab.