BD - 30
4 months ago
Vice President Regulatory Affairs & Quality
Location: San Diego, CA
Type: Full Time Permanent
Salary: Excellent salary, bonus and accompanying benefits package
Exciting opportunity to lead & develop Regulatory Affairs strategy with an exciting clinical, gene therapy company with a cutting edge technology platform
The Vice President of Regulatory Affairs will be tasked with leading, developing and implementing regulatory strategy, as well as building out a team to see products through registration. This person will also ensure compliance with GXP requirements.
Reporting directly to the C-Suite, this person, in collaboration with the CMO & CEO, will work out strategeic pathways for both US and Global regulatory submission. This person will also provide the oversight of cross functional teams as well as liaison with the FDA and other necessary authorities.
- Lead the development of US/Global regulatory strategy.
- Lead in the development of regulatory approaches, frameworks, and pathways.
- Provide the regulatory strategic leadership on application development productions, including the implementation of corporate objectives, dealing with submissions, and other regulatory requirements
- Develop and implement strategies for the timely preparation and execution of submissions to regulatory authorities for all phases of the product life cycle.
- Lead all Health Authority communications
- Communicate regulatory with stakeholders, internally and externally in order to comply with all noted objectives and deadlines
- Knowledgeable of US, EU and international regulatory affairs, GXP compliance and associated regulations.
- Bachelor’s Degree required (Masters, PharmD, or PhD preferred)
- Min of 12-15 years of Regulatory Affairs experience within the biopharma industry with at least 4 years in a senior capability
- Full life cycle of regulatory strategy specifically successful IND/NDA/MAA submissions
- Experience with orphan and fast track development product
- Well-rounded knowledge of FDA & EMA regulations
- Strategic thinker with the ability to thrive in a collaborative, fast paced environment
- Strong interpersonal communication skills, specifically in regard to the FDA/health authorities
- Demonstrate ability to work effectively in a cross functional manor while applying regulatory compliance knowledge
- Proven communication skills (written/verbal) and organizational skills in regard to prioritizing tasks in a deadline-oriented environment
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at 646-349-4344 or email@example.com