The Senior Associate/Manager, Regulatory Affairs, will report to the Associate Director, Regulatory Affairs and will primarily be responsible for assisting in the development and submission of US regulatory filings. These include investigational new drug applications, designation requests, meeting packages, and annual reports for multiple therapeutic programs.
Essential Duties and Responsibilities
- Devise and implement regulatory strategies under the direction of senior management.
- Develop and publish documents for regulatory submissions.
- Prepare submissions in electronic Common Technical Document (eCTD) format using a commercially available eCTD builder.
- Monitor the progress of regulatory filings. Communicate with regulatory authorities, as needed, in support of these submissions.
- Maintain awareness of relevant guidance documents from regulatory authorities.
- Additional responsibilities may be assigned commensurate with the experience of the candidate.
- Perform other duties as required.
- Bachelor’s degree required; advanced degree or equivalent experience preferred; concentration in life sciences, technical/engineering, or related field preferred.
- Minimum of 1 year of regulatory affairs experience required; 2 or more years of experience preferred.
- Experience in the development and submission of regulatory filings preferred.
- Strong communication and interpersonal skills.
- Precise attention to detail.
- Strong problem-solving and analytical skills.
- Ability to work with rapid changes: flexible and able to balance competing priorities.
- Ability to learn and apply pertinent regulations specific to functional work team.
- Self-motivated and capable of working in a diverse, fast-paced, and dynamic environment.
- Basic computer skills, including Microsoft Office Suite.
- Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.
The job will occasionally require standing for long periods, the ability to lift up to 25 pounds, and repetitive motions.