Senior Lead, Regulatory Affairs

**OBJECTIVES**:

- The incumbent is responsible for providing regulatory support and guidance to project teams in order to have the development strategy aligned with expectations of any major regulatory agencies globally that might be considered relevant for a specific program.
- To manage the planning process from development of regulatory strategies at early preclinical stages and potentially to product approval phase, with emphasis on early development given the objectives of Hilleman Labs.
- Act as an in-house regulatory expert, advising and supporting different project teams.
- Ensure compliance with major international regulatory requirements pertaining the product development in order to ensure ultimately product approval.

**RESPONSIBILITIES**:

- Work with extended leadership to devise regulatory strategies to ensure most appropriate path forward for products in development
- Interpret existing or new regulatory requirements as they relate to company products and procedures, clinical studies, testing, and/ or record-keeping.
- Provide regulatory guidance and support to project teams including regulatory filing strategies, testing and standards requirements and support RA staff in filing process.
- Review, analyse and support approval of technical data generated by preclinical Research and Development, Manufacturing, Clinical Research, Quality Assurance or other related departments for filing purposes.
- Support/Participate as the Regulatory CMC Lead on CMC/Value Chain Teams by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.
- Review, provide feedback and approve design of various R&D steps in product development.
- Prepare relevant regulatory submissions.
- Manage multiple workstreams and projects. Make sound and timely decisions based on project priorities. Discern paths forward within ambiguous environments.
- Advise on international product registration and other approval requirements.
- Act as a direct liaison with regulatory authorities. Respond to requests from regulatory authorities. Conduct conference calls, meetings and presentations with national regulatory authorities’ reviewers and/or inspectors as needed.
- Develop regulatory processes and procedures as needed.
- Maintain corporate confidentiality at all time.
- Other duties as assigned.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- A Bachelor’s Degree in Science of Life Science or Engineering or equivalent (MS preferred).
- Possess at least 12 years of experience in the pharmaceutical industry, consisting of at least 10 years in Regulatory Affairs. Experience in CMC regulatory affairs with biologicals (vaccines and monoclonal antibodies) is strongly preferred.
- Must be able to work independently and be able to multitask in a timeline driven start-up environment.
- Have a solid knowledge of major global regulatory processes. Have extensive experience in the preparation, and submission of development dossiers. Ability to interact, present and negotiate with key regulatory agencies.
- Must have excellent verbal and written communication, presentation skills, including experience presenting at FDA/EMA and/or other large national regulatory authority meetings.
- Must be able to communicate clearly and effectively over the phone and in writing with various clients including Regulatory Agencies.
- Must have strong interpersonal skills and management experience.
- Work requires willingness to work a flexible schedule. Experience with early development important
- Experience operating globally in a matrixed organization highly preferred
- Experience defining the strategy and roadmap for complex, cross-functional CMC initiative.
- Self-motivated individuals, have good interpersonal and communication skills, capable of analysing and solving complex problems through innovative thought and experience, as well as project management tools.