Director (Senior Director), Regulatory Affairs

About us

Shattuckians are a diverse group of physicians, scientists, drug developers and protein engineers that are linked through our shared desire to build transformative medicines for patients suffering from life-altering diseases. We are experts in the biology of TNF receptors, including DR3, and have assembled one of the most experienced teams in the industry with regard to understanding the immuno-biology of TNF receptor agonists and antagonists.

Summary

The Director (Senior Director), Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment with and in compliance with local and regional requirements, and company policies. This role is intended to be the key program team representative from Regulatory Affairs for global programs just prior to Phase 1 through completion of Phase 3. This role will also ensure effective communication and coordination with business partners within and outside of the company, and with regulatory authorities worldwide. Included among the necessary activities are: oversight of regulatory CRO activities, planning and leading: meetings with regulatory authorities, compilation and submission of high-quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports, annual reports. This position will be onsite in Durham, NC and the role level will be commiserate on candidate's experience.

Responsibilities

• Provide regulatory strategic input for global drug development projects, including but not limited to regulatory requirements, opportunities for expedited development, timing and content of agency interactions to support successful development programs.
• Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, responses to information requests and questions, safety reports, and annual updates/DSURs for assigned projects.
• Interpret and communicate regulatory expectations to stakeholders in order to execute program objectives in compliance with applicable regulations.
• Maintain an awareness and apply a comprehensive understanding of relevant regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
• Ensure that company and project team objectives and timelines are supported by regulatory deliverables.
• Provide de-risking development strategies and evaluate opportunities to accelerate development in a fast-paced environment.
• Represent Regulatory Affairs on global project teams, sub-teams, and external alliances.
• Provide oversight of Regulatory staff at CRO executing clinical trials.
• Provide support to clinical study related activities, including interacting with CROs as needed.
• Develop and implement data management strategies aligned with company objectives.
• Work as a member of a team, fostering constructive working relationships with internal and external colleagues.

Qualifications and skills

• Bachelor's Degree in clinical, scientific, medical or industry-related discipline is required; Advanced degree (MS, PharmD, PhD) preferred.
• Minimum of at least 8 years experience as a regulatory professional in the bio/pharmaceutical industry, including experience with successful interactions directly with regulatory agencies.
• Proven track record of successful regulatory submissions in the US and Europe, including major submissions (e.g., IND, CTA, BLA, NDA), and management of active programs (e.g., annual reports, safety reporting).
• Excellent knowledge of FDA, European Agencies and ICH regulations and guidance documents, and an ability to discern regulatory requirements in additional countries.
• Knowledge of drug development, and regulatory aspects of clinical study design, biostatistics, pharmacokinetics.
• Exercises good judgement in elevating and communicating potential or actual issues to line management.
• Proven track record of effective collaboration with multi-faceted project teams.
• Excellent written and oral communication skills with an ability to clearly articulate regulatory viewpoints to diverse audiences.
• Excellent interpersonal skills.
• Formatting skills in MS Word.
• Ability to work independently in a highly dynamic drug development environment.
• Capable of multi-tasking, setting priorities, and meeting timelines.
• Strong project management skills and drive for excellence.

Preferred, Additional Qualifications and skills

• Experience in a Biotechnology company.
• Familiarity with regulatory aspects of biologics manufacturing, including prior oversight of and responsibility for submissions that include CMC documentation.
• Experience with inflammatory bowel disease drug development.
• Scientific background in immunology, cell biology, preclinical assays
• Document formatting to ensure suitability for regulatory submission gateways.
• Experience in both early and late stage drug development.
• Recent experience with BLA, NDA, MAA.
• Experience with EU-CTR, IVDR, FDA NextGen Portal.

Employee benefits

• Competitive salary and health benefits, 401K.
• Opportunities for training and career advancement.
• Collaborative and inclusive work environment.
• Access to cutting-edge research and technology.

Note to External Recruiters

Our Human Resources department manages all open positions and candidate recruitment. We ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. We will consider failure to comply with this request when determining whether to enter a professional relationship with a recruiting agency. The submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise.