Regulatory Affairs Manager | Biologe (m/w/d)
Randstad Deutschland GmbH & Co. KG
Job Summary
This role is for an experienced Regulatory Affairs Manager seeking a stable position within a solid pharmaceutical company in or around Berlin. The successful candidate will be responsible for developing, aligning, and implementing global regulatory strategies to ensure timely submissions and first-cycle approvals for assigned development projects. Key responsibilities include interacting with health authorities to present and negotiate development plans and product labels, as well as leading a global regulatory team to coordinate worldwide regulatory input. The ideal candidate will possess a strong background in life sciences, significant experience in medical research, and proven expertise in both local and global regulatory affairs.
Required Skills
Education
Higher technical degree (Ph.D., DVM, or Pharm D.) in Life Sciences, or a completed university degree with extensive medical research experience.
Experience
- Several years of medical research experience, including local and global regulation in a related therapeutic area
- Professional experience with regional HA regulations and advanced knowledge of global regulations
- Proven interaction with local health authorities
- Demonstrated leadership and project management skills
Languages
Additional
- Not specified
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