Regulatory & Scientific Analyst

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.

Qualifications

• 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.

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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