Vice President Regulatory Affairs
Responsibilities:
- Develop and implement the company's regulatory strategy for all products aligned with business objectives and global regulatory requirements
- Ensure compliance with all applicable regulations, including those of the FDA, EMA, and other regulatory agencies
- Manage/Oversee preparation, review, and submission of regulatory documents for all products (IND, BLA, and international regulatory submissions)
- Interact with regulatory agencies on behalf of the company
- Provide regulatory guidance to other departments within the company
- Collaborate with Clinical Development teams to ensure regulatory compliance in clinical trial design, conduct and reporting
- Provide regulatory guidance to ensure trials are conducted in accordance with regulatory standards
- Work closely with cross-functional teams, including R&D, clinical, quality, and manufacturing, to ensure alignment on objectives to meet regulatory and post-licensure requirements.
- Stay up-to-date on the latest regulatory developments
Qualifications:
- Master's degree in a relevant field, such as pharmacy, law, or public health
- Advanced regulatory affairs certifications required.
- 10+ years of experience in regulatory affairs, with at least 5 years of experience in the advanced therapy space
- Experience in leading and managing a team of regulatory professionals
- Excellent written and verbal communication skills
- Ability to work independently and as part of a team
- Strong analytical and problem-solving skills, with a strategic mindset
Contact Information:
kasey@peoplewithchemistry.com
646-517-0307
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Seniority level
Executive -
Employment type
Full-time -
Job function
Strategy/Planning -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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