Position Purpose:
The Senior Manager/Associate Director of Regulatory Affairs reports to the Executive Director, Regulatory Affairs and will be responsible for contributing and delivering global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio. This role will provide regulatory support for various departments, projects, and teams.
Key Responsibilities:
- Develop and implement global regulatory strategies for assigned programs from early stage through commercialization, ensuring alignment with corporate objectives and regulatory requirements.
- Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority.
- Represent Regulatory on cross-functional product and study teams and provide strategic regulatory guidance and support to achieve product development objectives.
- Identifies and evaluates regulatory risks and establishes risk mitigation.
- Oversee the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
- Collaborate with internal and external stakeholders, manage and oversee third-party vendors and consultants to ensure high-quality submissions and successful execution of regulatory strategies.
- Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs.
- Contributes to the continuous improvement of existing processes and strategies, providing recommendations in their area of expertise.
- Stay current with evolving regulatory requirements and best practices, and ensure compliance with all applicable regulations, guidelines, and industry standards.
Required Skills & Experience:
- Bachelor's degree in health sciences or related field; an advanced degree is preferred.
- Minimum of 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs.
- Experience in rare disease drug development is highly desirable.
- Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
- Experience in working with US and EU Agencies; experience with Japanese Regulatory Agencies a plus.
- Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment.
- Proven ability to foster effective, positive interactions with regulatory agencies.
- Proven ability to demonstrate excellent leadership and communication skills.
- Strong interpersonal skills and proven ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
- Well organized, self-motivated hard worker, smart independent thinker, demonstrated ability to work well under pressure and deadlines, detail oriented, with effective written and oral communication skills.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in either our Bedford or Cambridge location.
Travel:
This position will require approximately 10% travel.
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