What are the responsibilities and job description for the Senior Director of Regulatory Affairs position at Skye Bioscience Inc.?
Join to apply for the Senior Director of Regulatory Affairs role at Skye Bioscience Inc.
This range is provided by Skye Bioscience Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
225,000.00 / yr - $250,000.00 / yr
Skye Bioscience takes pride in fostering a welcoming and inclusive community of passionate biotech enthusiasts who are united by their commitment to scientific excellence. Our workplace culture is built on fundamental values that guide everything we do : we champion supportive collaboration that enables breakthrough innovations, demonstrate purposeful and authentic passion in our pursuit of solutions, uphold unwavering integrity in all our actions, embrace personal and collective accountability, and maintain the highest quality standards in our research and development processes.
About the Role :
The Senior Director of Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership. This role will also oversee the life cycle management of all regulatory submissions and approvals. The position is responsible for oversight and execution of global regulatory activities, product registrations and applications (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.), and regulatory compliance. The position is expected to interface with cross-functional teams, internal senior leadership and external consultants. This role will also have experience with communicating and interacting with the US FDA and other global Regulatory Authorities.
Responsibilities
- Establish regulatory strategies and plans by collaborating and coordinating with relevant development team members - represent the regulatory function as a member of the core development team.
- Provides original writing and critical evaluation of regulatory documents, including an ability to master scientific and clinical content related to development and regulatory objectives.
- Manages timelines of pending regulatory submissions.
- Direct and lead execution plans for regulatory submissions.
- Proactively identify potential program and / or submission risks and implement appropriate regulatory mitigation strategies to support successful outcomes.
- Lead the coordination of regulatory meeting packages and lead Regulatory Authority meetings.
- Assist in the management and oversight of regulatory activities relating to clinical trials.
- Assist with the leadership of the regulatory team and use experience and expertise to provide guidance to the wider organization, including clinical, CMC, R&D, investor relations, and corporate development.
- Provide oversight and management of external regulatory vendors and regulatory resources.
- Advise on labeling, promotional review, and other post-marketing / commercial regulatory activities.
- Assure compliance with regulatory reporting requirements.
- Ensures process and standards documents (e.g., SOPs, work instructions, checklists) related to regulatory activities and obligations are in place and updated as needed.
- Ensures company is inspection-ready and serves as the on-site point of contact for any inspections by regulatory authorities.
- Perform other duties as required.
Qualifications
Actual base salary for this role will take into consideration factors such as relevant experience, skills and qualifications for the role. Skye currently offers health benefits for eligible employees.
You must be authorized to work in the United States (required).
As an equal opportunity employer, Skye Bioscience does not discriminate against any applicant or employee based on race, color, sex, sexual orientation, gender identity, marital status, religion, national origin, ancestry, age, disability, military or veteran status.
Compensation Range
225K - $250K
Seniority level
Director
Employment type
Full-time
Job function
Legal
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Salary : $225,000 - $250,000
