Medella Life has the opportunity to partner again with an outstanding client of ours who is considered to be a world leader in the healthcare industry! Headquartered in Europe, they are a multinational organisation who specialise within diagnostic imaging. They are in the process of expanding out their Regulatory department in the US and are seeking an Associate Director, Regulatory Affairs to join their dynamic team! You will be surrounded by market leading experts who provide in depth industry knowledge and uou will have the opportunity to work alongside them to shape the future of the company.
The role
The Associate Director is a regulatory affairs generalist responsible for regulatory affairs support for confidential drug products approved and marketed in the US. The Associate Director assists the Director of U.S. Regulatory Affairs.
Responsibilities
Essential Activities, Duties, Tasks and Responsibilities
- Assist the Director to manage submission of (including but not limited to) INDs, and NDAs, supplements, amendments, annual reports, etc.
- Review and provide submission letters and FDA forms for submissions to FDA or other US regulatory agencies
- Direct and oversee / conduct regulatory reviews and approvals of promotional materials and marketing activities
- Serve as the secondary contact for FDA.
- Maintain current knowledge and understanding of FDA regulations, guidance, and other U.S. regulatory standards
- Provide timely and accurate regulatory guidance to key partners/departments to assure adequate and complete submissions
- Responsible for generation of CPP requests
Secondary Activities, Duties, Tasks and Responsibilities
- Serve as the regulatory expert on various projects, including new product development projects, NDA submissions, and studies, including preclinical and clinical
- Provide US regulatory updates regarding products as needed for generation of PSURs and PBERs
Supervisory Responsibilities
- This role may include supervision of contract and temporary employees, as may be required.
Education
- Minimum of a Bachelor’s degree in a scientific or health related discipline.
Professional Experience, Knowledge & Technical Skills
- Minimum of five years of experience in general regulatory affairs, including regulatory agency interactions
- Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
- Experience in Veeva software application is a plus
- Strong written and verbal communication skills
Managerial Skills
- Assertive and willing to make decisions
- Ability to juggle multiple competing tasks and set clear priorities
- Organized and delivery focused
- Ability to work independently in fast-paced environment with little supervision
Core Relationships
- Marketing
- Group Commercial Operations
- Corporate Quality Management and Quality Assurance in BDI
- Non-clinical research (i.e. pharmaceutics)
- Other functions within Medical and Regulatory Affairs
- Contract manufacturers (regulatory affairs, QC/QA, etc.)
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything