Senior Regulatory Affairs Specialist
The function of a Senior Regulatory Affairs Specialist is to combine knowledge of scientific, regulatory, and business issues to enable radiopharmaceutical products that are developed, manufactured, or distributed to meet required legislation. The Senior Regulatory Affairs Specialist will have primary responsibility to compile, and file DMFs, ANDA/NDAs, related amendments and supplements and acquire the appropriate marketing approvals while ensuring compliance with applicable FDA regulations. Secondary responsibilities will be to obtain appropriate international registration with appropriate competent authorities as required by company strategic planning.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Lead multidisciplinary teams on the content, format, style, and architecture of marketing applications and the strategies for gaining regulatory approval. Write and/or review submission sections and evaluate relative to development strategy and conformance with the regulatory requirements.
2. Contribute to multidisciplinary teams with respect to regulatory strategy for drug development including CMC and commercial requirements through successive stages of development. Apply and advance knowledge of U.S. and international requirements/guidelines applicable to same.
3. Contribute to global communications for regulatory authorities on all aspects of a product offering: annual updates and responses to requests for information in accordance with company policies and practices.
4. Contribute to multidisciplinary teams on the regulatory requirements for publically shown materials, including promotional materials.
5. Lead multidisciplinary teams on the content, format, and style of New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Drug Master Files, and related amendments and supplements.
6. Assist with the communication and preparation of meeting with regulatory authorities and agencies.
7. Review critical analyses of data (clinical, preclinical, and manufacturing) and independently interpret and develop conclusions; perform reviews of clinical/preclinical/manufacturing protocols and study reports.
8. Maintain responsibility for the regulatory strategy related to CMC for life cycle maintenance of marketed and pre-market product offerings.
9. Closely collaborate with Technical Operations team members and other key partners both internal and external to the company, aimed at ensuring regulatory documentation meets project target dates.
10. Execute pre- and post-approval regulatory submissions including annual reports, renewals, supplemental applications briefing packages for FDA meetings, Health Canada, or EU scientific advice procedures and other maintenance dossiers and coordinate responses to health authority questions and comments.
11. Review Technical Operations and Development documentation for regulatory compliance including validation protocols, close out reports, analytical methods, batch records, and any other RA-CMC related documentation.
12. Serve as the primary contact for RA-CMC documentation materials and questions.
13. Mentor other Regulatory team members on internal and external systems, technology, regulatory requirements, and related policies and procedures.
14. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
15. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.
Ability and willingness to travel, both domestically and internationally, up to 20% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in Biology, Chemistry, or other related subject and six or more years of experience in the pharmaceutical industry, with a minimum of three years in Regulatory Affairs, R&D, or Quality Assurance; or equivalent combination of education and experience. Experience with Radiopharmaceuticals, RAC Certification, and eCTD Submission experience is preferred.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel.
• Excellent communication skills, verbal and written
• Ability to work in a team environment, as well as independently
• Ability to handle multiple projects simultaneously
• Ability to work in a fast-paced environment
• Adaptable to change in the work environment
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line