Provention Bio is searching for a Director, Regulatory Affairs to join their Regulatory Affairs group. This position will work collaboratively with colleagues to meet regulatory goals and timelines. This role will be responsible for leading, preparing, and managing regulatory submissions, queries, and interactions for both investigational and commercial products. In addition, this position will assist in the preparation and review of biologics CMC sections of applications and in managing responses to CMC queries from regulatory authorities. Flexibility is required in project assignments dependent the company’s needs. This position reports to the Sr Vice President, Regulatory Affairs.
- Represent Regulatory Affairs at product development team meetings
- Lead, prepare, and track designated submissions to regulatory agencies, both for investigational and commercial products. These may include regulatory submissions such amendments, supplements, annual reports, responses to regulatory authorities, etc. for INDs, CTAs, BLAs, and MAAs.
- Guide, manage and assist in the preparation of biologics CMC sections of regulatory applications
- Lead and assist in the preparation of responses to CMC queries from regulatory authorities
- Communicate and interact with regulatory authorities for assigned projects
- Archive and maintain regulatory documents and communications with authorities
- Assist with development of SOPs as requested.
- Work collaboratively with other members of the Regulatory Affairs group to complete assignments and meet timelines
- Act as a regulatory resource to the company for regulatory agency processes, expectations, guidelines, and compliance.
- Manage and interact with regulatory consultants and external contractors, as needed
- Maintain a positive work environment with internal colleagues and external partners
- Other duties as assigned.
- Bachelor’s, Master’s or PhD/PharmD in the sciences
- Six + years pharmaceutical/biotechnology industry experience with a minimum of 4 years in Regulatory Affairs.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Experience with biologics CMC regulations and regulatory submissions.
- Excellent written, verbal, and communication skills. Expertise in Microsoft Office Software, particularly Word. Ability to learn and use other relevant software as needed.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing staff, and external contractors.
Provention Bio is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment is decided based on qualifications, merit, and business need.
To apply, please send resume and cover letter to: firstname.lastname@example.org