Regulatory Affairs Consultant

Cullgen • San Diego, CA

76d

About The Position

We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. You will work collaboratively with other functional leaders across the organization, as well as external stakeholders. Our ideal candidate will have experience leading the regulatory function in different therapeutics areas and includes both tactical and strategic responsibilities.

Requirements

• 15+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
• D., PharmD or other relevant post-graduate level training strongly preferred.
• Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
• Experience with Type D meetings and responses needed.
• Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions supported by appropriate tactics.
• Ability to occasionally work onsite from our San Diego offices.

Responsibilities

• Work with the team to compile submissions of original IND and responses to all regulatory authority queries.
• Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), internal preparation and agency meetings.
• Serve as a company contact with the FDA and other regulatory authorities.
• Ensure all external data complies with required specifications, standards, protocols, SOPs and overall clinical objectives.
• Enable creative solutions to regulatory challenges to timely advance therapeutics to meet key development milestones including positioning for successful pivotal trials and registration.

What This Job Offers

• Job Type: Part-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees