Senior Director of Regulatory Affairs

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. These principles form the foundation of our approach to advancing therapeutic solutions and improving patient outcomes.

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

As the subject matter expert for regulatory affairs the Senior Director of Regulatory Affairs will assist in leading and managing all regulatory activities at the company and will report directly to the Chief Medical Officer:

• 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

• Bachelor's Degree required; Advanced Degree preferred

• Bachelor's degree Life/Health Sciences; Master's degree and/or Ph.D. a plus

• Minimum of 8-10 years of experience in pharmaceutical / biotech industry

• Minimum 4-6 years in a management role within Regulatory

• Comprehensive knowledge of current US and ex-US regulations and guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies and assessment of risks related to regulatory and development activities

• Experience developing products, including INDs, CTAs, NDAs/BLAs, MAAs, expedited approval pathways, etc.

• Proven ability to establish strategy and to translate it into an effective, long term action plan

• Demonstrated success in effectively leading regulatory teams

• Thorough understanding of the regulatory process from development through commercialization

• Strong project management skills

• Strong written and oral communication skills

• Able to grasp complex technical issues and make sound decisions based on data and information from various sources

• Ability to foster and promote internal collaboration

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 Stronghold 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,