Regulatory Affairs Specialist
The Regulatory Affairs Specialist will have primary responsibility to assemble documentation to support the filing of DMFs, ANDA/NDAs, related amendments and supplements while ensuring compliance with applicable FDA regulations. Secondary responsibilities will be to support appropriate international registration with appropriate competent authorities as required by company strategic planning.
The function of a 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 individual will support activities within the department and function as a resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain this data and ensure that it is effectively presented for the registration of products worldwide.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
Provide support for 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.
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.
Provide support for global communications to regulatory authorities by the corporation on all aspects of a product offering: annual updates, responses to requests for information, in accordance with company policies and practices.
Assist with communication to regulatory authorities and participate in regulatory meetings with regulatory agencies.
Contribute to the review of critical data (clinical, preclinical and manufacturing) and interpret and develop conclusions; perform reviews of clinical/preclinical/manufacturing protocols and study reports.
Provide the regulatory strategy related to CMC for life cycle maintenance of marketed and pre-market product offerings.
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.
Provide support for 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.
Contribute to the review of 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.
Serve as a secondary contact for RA-CMC documentation materials and questions by multidisciplinary teams.
Maintain current knowledge of, and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
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 15% 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 Chemistry, Biology or other related scientific discipline and three to five years of experience in the biopharmaceutical/pharmaceutical or related industry with direct Regulatory experience; or equivalent combination of education and experience. Experience with Radiopharmaceuticals, RAC Certification, and eCTD Submission experience preferred.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel. Familiarity with publishing software preferred.
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