Manager, Regulatory Affairs

Job Description - Manager position reports to the Associate Director, Regulatory Affairs Development
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned project and programs (for both internal and corporate partnered programs)
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs for the U.S., including coordinating regulatory workflow, leading regulatory submission teams, tracking submission timelines, and reviewing technical documents (clinical and non-clinical information)
- Provides clear and valid regulatory guidance and direction to other departments and project teams
- Interacts with regulatory agencies regarding assigned projects or programs, as appropriate
- Participates and contributes to health authority meetings
- Represents regulatory affairs on relevant project teams
- Mentors other regulatory staff members as needed

Qualifications
- BA/BS/University degree required, Life/Health Sciences preferred
- Minimum 5+ years pharmaceutical/biotechnology industry experience, at least 2 years in regulatory affairs
- Ability to work independently with minimal direction and within project teams, committees, etc. to attain group goals
- Demonstrate excellent communication skills
- Ability to represent the department on project teams
- Demonstrate strong organizational skills, including ability to prioritize personal workload and workload of direct reports (as applicable)
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Demonstrated effective cross-cultural awareness and capabilities
- Experience in interfacing with relevant regulatory authorities
- Experience and knowledge in the preparation of major regulatory submissions (INDs, NDAs, MFs, BLAs) and supportive amendments or supplements
- Knowledge and understanding of applicable regulations
- Experience in the interpretation of regulations, guidelines, policy statements, etc.
- Computer literate
- Sensitivity for multicultural/multinational environment

Education
BA/BS/University Degree in scientific discipline required, preferably in Life/Health Sciences