About this role
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.
- 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.