Regulatory Project Manager
4 days ago
We are seeking a highly motivated and experienced Regulatory Project Manager to join our team at Genmab. As an Associate Director, Global Regulatory Affairs Project Lead, you will be responsible for ensuring regulatory compliance and oversight for our clinical trials, as well as developing and executing EU/ROW strategies for assigned projects.
In this role, you will represent RA in Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure timely and successful completion of clinical trial submissions in EU/ROW. You will also have the opportunity to act as EU/ROW regulatory strategy lead for one or multiple compounds in early development, providing regulatory expertise and guidance on procedural matters and documentation requirements.
Responsibilities:
- Ensure regulatory compliance and oversight for clinical trials.
- Develop and execute EU/ROW strategies for assigned projects.
- Collaborate with CROs and internal stakeholders to ensure timely and successful completion of clinical trial submissions.
- Prepare and submit regulatory documents, including Briefing Packages, ODDs, PIPs, etc.
- Liaise with EMA and national health authorities to ensure compliance with regulatory requirements.
Requirements:
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. Master's degree preferred.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
- Proven track record of success in regulatory affairs, with a focus on clinical trial submissions.
- Strong understanding of EU regulatory procedures and experience within oncology will be a plus.
- Prior experience leading health authority meetings with EMA or other health authorities will be a plus.
- Excellent communication and project management skills.
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