About the company
My client is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. They are in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. My client is also developing its second based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with confidential to develop and commercialize confidential for dermatologic oncology conditions. If you want to work in an environment that uses your unique skills and abilities in a fast-paced, small-pharma environment, they are the team for you!
The Executive Director of Regulatory Affairs will be responsible for providing strategy and guidance for regulatory activities and leading all regulatory submissions. This role will serve as the primary interface with regulatory authorities and manage external partners assisting in regulatory submissions and responses. This position reports to the Chief Legal Officer and is responsible for presenting to senior leadership on progress against objectives and plans.
- Ensures high-quality, complex regulatory submissions including INDs, milestone briefing packages (Pre IND/NDA Meetings, EOP2 Meetings, and Type A and Type C Meetings), NDAs, and other major US/Global regulatory submissions are sent to Health Authorities according to regulatory/company timelines
- Provides Regulatory Affairs oversight and direction to external Regulatory Affairs vendor(s) for regulatory submissions
- Serves as primary Regulatory Affairs contact with Health Authorities for regulatory compliance and US/global product registrations
- Provides regulatory input for CMC, Nonclinical, and Clinical regulatory documents for submission to Health Authorities
- Provides overall Regulatory Affairs strategy and guidance to the Senior Leadership Team on emerging Health Authority trends, regulations, and guidelines
- Develops and maintains strong relationships with key stakeholders and regulatory Health Authority officials
- Leads Regulatory Affairs strategy for Health Authority meetings and teleconferences
- Monitors competitor regulatory landscape and communicates regulatory trends to Leadership Team that may have an impact on the company
- Provides Regulatory Affairs strategy, guidance, and contributes to reviews of disease- awareness and promotional Marketing campaigns to ensure compliance
- Represents Regulatory Affairs on cross-functional teams
- Represents the company Regulatory Affairs at External Meetings
- Maintains compliance with Regulatory budget and SOPs
- Bachelor's degree. At least 15+ years of progressively responsible experience in Regulatory Affairs within the pharmaceutical and/or medical device industries Demonstrated experience and expertise in providing successful regulatory strategies and outcomes with Health Authorities
- Must have extensive knowledge of the regulations, regulatory process, and requirements Extensive experience in regulatory submissions including INDs, milestone briefing packages (Pre IND/NDA Meetings, EOP2 Meetings, and Type A and Type C Meetings), NDAs, and other major US/Global regulatory submissions
- Advanced degree in scientific discipline relevant to drug discovery and development preferred
- Strong written and oral communication skills
- Committed to the company’s vision, mission, core values and culture.
- Must be able to sit for extended periods of time at a desk. Normal requirements for office operations.
- The position is based in PA