What are the responsibilities and job description for the Senior Director Regulatory Affairs position at Blue Lake Biotechnology?
Employment type: Full-time, exempt, onsite
Location: Athens, GA
About Blue Lake Biotechnology, Inc.
Blue Lake Biotechnology is a private intranasal vaccine company harnessing the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the lives of vulnerable populations. We aspire to transform the healthcare landscape and create a healthier world with better vaccines for all ages that are painless, easy, and effective. Our PIV5-vectored Covid-19 vaccine and RSV vaccine are in phase 2 clinical trials.
Job Description:
Senior Director Regulatory Affairs
The Senior Director of Regulatory Affairs will be responsible for overseeing all regulatory affairs activities related to the development of novel intranasal delivered vaccines. This role will involve directing regulatory submissions, ensuring compliance with regulatory requirements, and actively engaging with regulatory authorities. The ideal candidate will have a strong background in vaccine/biologics development and experience in managing regulatory processes within a start-up biotech company.
Responsibilities
- Lead all aspects of regulatory affairs.
- Develop and implement regulatory strategies for product development that align with business objectives and timelines.
- Oversee the preparation and submission of regulatory documents including INDs, CTAs, BLAs, and NDAs to the FDA and other regulatory authorities.
- Serve as the primary point of contact for regulatory agencies and facilitate communication between the company and regulatory bodies.
- Plan, prepare for, and help lead regulatory agency meetings.
- Execute the regulatory strategy for the program, which may include pre-IND, EOP1, EOP2, IND, CTA, IMPD, BLA, orphan designations, fast track, and breakthrough designation filings.
- Prepare and oversee submission of regulatory documents. Ensure regulatory commitments and requirements are fulfilled on time and of high quality.
- Provide expert regulatory guidance to cross-functional teams, including clinical development, CMC, preclinical development.
- Monitor and interpret FDA regulations, guidelines, and industry standards; ensure company practices are compliant with these requirements.
- Communicate to leadership timely updates on changes to regulatory requirements, or other issues that may impact product development.
- Prepare/review SOPs. Review and/or provide medical writing support for study documents (Protocol, Consents, Investigator’s Brochure, IND clinical and non-clinical sections).
- Work closely with quality assurance to develop quality strategy and systems in support of product development and clinical trial activities.
- Keep up to date on changing regulatory landscape.
Qualifications
- Bachelor’s degree in a relevant scientific discipline; advanced degree (PhD, MD, PharmD or equivalent) preferred.
- Minimum of 10 years of experience in regulatory affairs, with specific experience in vaccine/biologics development.
- Proven track record of leading successful regulatory submissions and interactions with regulatory agencies. Must have led Agency meetings.
- Deep understanding of FDA regulations, and international regulatory requirements (EMA, ICH, etc.).
- Strong leadership skills with experience managing cross-functional teams.
- Excellent communication, negotiation, and interpersonal skills.
- Ability to work in a dynamic start up environment, demonstrating flexibility and adaptability.
Additional Information:
The company strives to offer a competitive benefit package for our employees including but not limited to the following:
- Health, dental, and vision insurance
- 401(k)
- Paid time off
