Master's degree in biological sciences or related field; PhD, PharmD, or MD preferred.
Extensive scientific writing experience, with peer-reviewed publications strongly preferred.
Experience in preparing clinical study reports and regulatory submissions.
Strong verbal and written communication skills.
Proficiency in MS Word, Excel, PowerPoint; MS Visio experience preferred.
Strong analytical skills with attention to detail.
Ability to work independently and collaboratively.
Responsibilities
Write and review technical reports summarizing scientific papers and study data.
Prepare and review regulatory submissions including IND, NDA, IDE, PMA, DMF, BLA, and 510(k).
Assist in developing and editing Investigator Brochures, annual reports, and clinical protocols.
Coordinate document preparation and submission activities with internal and external teams.
Support electronic formatting and submission of regulatory filings.
Review reports and listings for completeness and accuracy.
Collaborate with clinical and statistical teams to synthesize data.
Benefits
Comprehensive regulatory, quality, and clinical support.
Opportunity to work across the product life cycle in various sectors.
Engagement with a team of experts in navigating complex regulations.
Potential for managerial responsibilities in regulatory affairs training and FDA meeting preparation.
Full Job Description
Job Description
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.
Responsibilities
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.
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Qualifications
Master's degree in biological sciences or related field; PhD, PharmD or MD.
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.
About the Team
From research to patient, NSF's expert team provides comprehensive regulatory, quality and clinical support to pharmaceutical, biotech, medical devices, in-vitro diagnostics, and combination products clients across the product life cycle to navigate complex regulations and industry challenges.
About NSF International
NSF International is a global public health and safety organization that provides testing, inspection, and certification services for a wide range of products and industries. The company was founded in 1944 and is headquartered in Ann Arbor, Michigan. NSF International operates in over 175 countries and has offices and laboratories around the world. The company's services include food safety and quality, water quality, environmental health and safety, sustainability, and management systems certification. NSF International is a non-profit organization and is accredited by various regulatory bodies and industry associations.
