Senior Manager/Associate Director, Regulatory Affairs

Title: Seeking a Senior Manager/Associate Director for Regulatory Affairs

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. 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 stages through commercialization, ensuring alignment with corporate objectives and regulatory requirements.
• Responsible for regulatory communications with local health authorities; 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.
• Identify and evaluate regulatory risks and establish risk mitigation strategies.
• 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.
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
• Contribute 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 working with US and EU Agencies; experience with Japanese Regulatory Agencies is 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.
• 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, independent thinker, demonstrated ability to work well under pressure and deadlines, detail-oriented, with effective written and oral communication skills.

Culture & Values: Innovation, the ability to successfully advance groundbreaking science, and having fun as a team are enhanced by being together in person, at least periodically. Flexibility in work arrangements that balance individual needs and preferences with the business needs and the desire to foster a culture of collaboration and innovation is valued.

Values guide the work to deliver meaningful medicines for people who need them. There is a commitment to being true to oneself, to colleagues, and to people with severe diseases who are counting on the company. Diversity is embraced within a unique culture defined by values. An employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.