AD/Director Regulatory Affairs
**This position requires being onsite in San Diego. Please do not apply if you are looking for a remote only position. This position will be 50% in the office, 50% work from home. We will consider local candidates or someone who is open to relocating to sunny San Diego!**
- Provide regulatory support (defined in Section III.2.c) to product development objectives through organized and timely regulatory submissions.
- Ensure that the timing and content of regulatory submissions meet regulatory agency expectations and achieve regulatory clearance without delaying manufacturing timelines, clinical trial timelines and other development activities.
- By organizing effective document review processes ensure completeness, accuracy and appropriate messaging of regulatory submissions.
- Proactively assist development teams and management in awareness and understanding of new and evolving regulatory requirements and their impacts.
- Contribute to continuous improvement through the QMS.
- Ability to project a positive constructive attitude in communications to inspire cooperation and teamwork among peers and management members.
Skills and Requirements:
- Minimum of a bachelor's degree in biological sciences or related field is required.
- Regional scope: 7 years' experience in providing regulatory support to sponsors (manufacturers, specification developers and/or dossier applicants) in U.S.; experience with Canada, UK, or EMA or EU member states is a plus.
- Product life-cycle scope: Experience with investigational medical products development; experience with commercial stage medical products is desired.
- Regulatory support scope: Experience providing such work products as: clinical trial applications (INDs), amendments and associated meeting packages and written communications for biological drug products; medical device pre-market clearance applications (510(k)s, PMAs) in combination with parenteral biologic or drug products, and associated pre-submission packages; or biologic or drug product market authorization applications (NDA's, BLA's, MAA's or PMA's); maintaining logs and archives of searchable and retrievable regulatory agency written and verbal communications.
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.