Regulatory Affairs Manager

Regulatory Affairs Manager Balance Staffing New England•5.0 Andover, MA Job Details Full-time $130,000•$145,000 a year 1 day ago Benefits Health savings account Health insurance On-site gym Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Vision insurance 401(k) matching Life insurance Qualifications Drug regulation English Clinical research compliance Bachelor's degree Pharmaceutical company experience Project management in healthcare Compliance documentation Biomedical regulatory compliance Managing projects English Cross-functional communication Full Job Description Direct Hire position;

Hours:

Monday•Friday, 8:30am•5pm. (

Hybrid:

3 days in Andover, 2 days at home) Job Summary We are seeking a highly skilled and detail-oriented Regulatory Affairs Manager to join our dynamic team. In this pivotal role, you will oversee the development and implementation of regulatory strategies to ensure compliance with applicable laws and standards across our product portfolio. Your expertise will facilitate successful product approvals, maintain adherence to evolving regulations, and support the company's commitment to quality and safety. The ideal candidate will possess a strong background in regulatory processes within the healthcare or pharmaceutical industry, with a focus on fostering compliance and advancing research initiatives. Duties Develop, execute, and monitor regulatory strategies aligned with company objectives and industry standards. Prepare and submit regulatory documentation to agencies such as the Food and Drug Administration (FDA) and other relevant authorities. Ensure all products meet current regulations related to chemistry, manufacturing, and controls (CMC), clinical trials, and quality assurance. Maintain up-to-date knowledge of regulatory changes affecting product development, manufacturing, and marketing. Collaborate with research teams to facilitate clinical trial approvals, modifications, and reporting requirements. Manage compliance documentation, including registration dossiers, safety reports, and audit responses. Lead cross-functional teams to ensure timely submission of regulatory filings and adherence to project timelines. Conduct internal audits to verify compliance with applicable regulations and standards. Provide training on regulatory requirements to internal departments to foster a culture of compliance. Support product lifecycle management by advising on labeling, packaging, and post-market surveillance activities. Requirements Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or a related field; advanced degrees are preferred. Proven experience in regulatory affairs within the healthcare or pharmaceutical industry. Extensive knowledge of FDA regulations governing drug development, clinical trials, manufacturing practices, and quality assurance. Familiarity with research protocols and clinical trial processes. Strong understanding of compliance management systems and documentation practices. Excellent project management skills with the ability to coordinate multiple initiatives simultaneously. Demonstrated ability to interpret complex regulations and communicate effectively across departments. Experience with regulatory software tools and submission platforms is advantageous. If you are committed to ensuring product safety through rigorous compliance management while supporting innovative research efforts, we encourage you to apply. Join us in advancing our mission by ensuring that our products meet the highest standards of quality and regulatory excellence.

Pay:

$130,000.00•$145,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Life insurance On-site gym Paid time off Tuition reimbursement Vision insurance

Education:

Bachelor's (Preferred)

Language:

English (Required)

Location:

Andover, MA 01810 (Required)

Work Location:

Hybrid remote in Andover, MA 01810