Luminary Group is seeking a highly skilled and experienced Vice President of Regulatory Affairs to join our client. As the Vice President of Regulatory Affairs, you will play a critical role in the development and implementation of regulatory strategies to support our client's products in the pharmaceutical, biotechnology, and medical device industries.
Responsibilities:
- Lead the regulatory affairs function and provide strategic guidance to ensure compliance with global regulatory requirements.
- Develop and execute regulatory strategies for product development, registration, and post-approval activities, ensuring timely and successful regulatory submissions.
- Interact with regulatory authorities and participate in meetings and negotiations to address regulatory issues and ensure alignment with company objectives.
- Monitor and interpret changing regulatory trends and requirements, and provide guidance on potential impact to the organization.
- Collaborate with cross-functional teams to review and prepare regulatory submissions, including INDs, NDAs, BLAs, and marketing applications.
- Oversee the preparation of regulatory documents, including briefing packages, responses to regulatory inquiries, and labeling changes.
- Ensure compliance with regulatory reporting requirements and timelines.
- Manage and mentor a team of regulatory professionals, providing guidance, training, and performance evaluations.
- Stay up-to-date with global regulatory guidelines and requirements, and guide the organization in implementing best practices and industry standards.
- Collaborate with internal stakeholders to provide regulatory guidance and support for business development activities, including due diligence assessments and regulatory integration of acquired products.
Requirements
- Bachelor's degree in a scientific or related field; advanced degree (PhD, PharmD) preferred.
- Minimum of 10 years of experience in regulatory affairs in the pharmaceutical, biotechnology, or medical device industries.
- Demonstrated experience in developing and executing regulatory strategies for global product development, registration, and post-approval activities.
- Extensive knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
- Proven track record of successful interactions with regulatory authorities.
- Strong leadership and management skills, with the ability to effectively lead and develop a team.
- Excellent verbal and written communication skills, with the ability to clearly and convincingly present regulatory strategies and perspectives.
- Strong organizational and project management skills, with the ability to prioritize and manage multiple competing tasks.
- Experience working in a cross-functional team environment, collaborating with R&D, clinical, quality, and commercial teams.
- Knowledge of advanced therapy medicinal products (ATMPs) and/or orphan drug regulations is a plus.
Β
Luminary Group
International executive search and business consultancy specializing in the Life Sciences and Pharmaceutical sectors.
Updated Β
Other jobs at Luminary Group
Β
Β
Β
Β
Β
Β
Β
Β
Why OmniJobs?
- Rare & hidden jobs
- New jobs every day
- No expired job posts
- All jobs in English
Receive emails about similar jobs
Get alerts to your inbox about new open jobs that are similar to this one.
No spam. No ads. Unsubscribe anytime.
Similar jobs
Β
Β
Β
Β
Β
Β
Β
Β