The Regulatory Scientific Analyst / Regulatory Affairs Manager supports the preparation, development, writing, reviewing, and coordination of regulatory documents and scientific materials for submissions to the FDA and other regulatory agencies. This role contributes to regulatory strategy, document preparation, scientific analysis, and cross-functional collaboration. Depending on the candidate’s qualifications, responsibilities may include advanced regulatory coordination, FDA meeting preparation, and departmental support.
Write and review technical reports summarizing scientific papers and clinical/non-clinical study data.
Prepare, compile, and review regulatory submissions including IND, NDA, IDE, PMA, DMF, BLA, 510(k), and amendments.
Assist in developing, writing, and editing Investigator Brochures, annual reports, clinical protocols, and regulatory communications. • Prepare integrated tables, graphs, and figures for regulatory and scientific documents.
Coordinate document preparation and submission activities with internal teams and external partners.
Support electronic formatting and submission of regulatory filings.
Review reports, tables, and listings for completeness and accuracy.
Collaborate with clinical, data management, and statistical teams to obtain and synthesize data.
Participate in study teams, clinical project teams, and interdepartmental project meetings.
Prepare pre-IND meeting packages and assist with arranging FDA meetings (Manager-level responsibility). • Draft memos, SOPs, guidelines, and presentations.
Provide guidance on regulatory requirements, including FDA and ICH guidelines.
Develop procedures for new projects and provide direction to personnel or consultants.
Support training programs in regulatory affairs and related fields (Manager-level responsibility).
Other duties as assigned.
#LI-KS1
Master’s degree in biological sciences or related field; PhD, PharmD or MD.
Extensive scientific writing experience: peer-reviewed publications strongly preferred.
Experience preparing clinical study reports and regulatory submissions.
Strong verbal and written communication skills.
Proficiency in MS Word, Excel, PowerPoint; experience with MS Visio preferred.
Strong analytical skills, attention to detail, and follow-up skills.
Ability to work independently and collaboratively.
With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health. We provide science-driven, independent testing, inspection, certification, and advisory services and develop the very standards that drive the food, water, and life sciences industries worldwide. We empower our clients to navigate shifting regulations to improve consumer health, safety, and quality of life.
One of our core values is We Are One NSF. This means that while we’re one team, we embrace the cultural, ethnic, language, and demographic diversity that reflects the societies in which we live and work.
Come join a team that makes a difference in the world. More information about NSF can be found at nsf.org.
NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.
Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role. Resumes submitted to an NSF employee by a third-party agency without a valid written & signed search agreement between NSF and said third-party agency will become the sole property of NSF. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you.
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The National Science Foundation is an independent federal agency that supports fundamental research and education in all non-medical fields of science and engineering.