Piper Companies is looking for a Regulatory Affairs Manager to join a pharmaceutical manufacturer in Devens, MA. The incumbent provides regulatory oversight and support to the team’s assigned products and act as the site subject matter expert for all regulatory affairs matters. The incumbent helps developing strategies to ensure compliance to regulations and acts as a liaison between regulatory agencies and the Company for all matters related to regulatory submission The incumbent assist during customer audits and regulatory inspections at the site.
Responsibilities for the Regulatory Affairs Manager include:
- Accountable for regulatory submissions for the APIs manufactured at multiple company locations APIs, balancing the speed to file and the need for Right-first time submissions.
- Ensure that regulatory submissions are maintained up-to-date including, but not limited to, submission of annual updates.
- Accountable for the preparation of responses to regulatory deficiencies, partnering with the other functions to ensure that they are timely addressed.
- Perform gap assessments and risk analysis on existing regulatory submissions proposing remediation plans in line with the business strategies.
- Act as the Regulatory Subject Matter Expert for the assigned projects and for the site, regarding design, development, validation, commercialization of products throughout the product life-cycle.
- Help formulating regulatory strategies for internal use and for customers for the Innovator and Generic portfolios.
- Assess all proposed changes to facilities, processes and controls performing the regulatory impact assessment and suggesting the best regulatory strategy to implement the change.
- Review and/or approve reports, deviations, and other GMP documents for regulatory impact as required.
- Maintain current knowledge of relevant guidelines including proposed and final regulations. Monitor emerging trends regarding industry regulations. Share regulatory intelligence with the site and the global regulatory organization. Develop and propose plans to comply with the new requirements before they become effective.
- Prepare and maintain operating procedures concerning regulatory submissions and related activities. Implement policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Support the creation and maintenance of sector regulatory policies and procedures to harmonize and enhance the regulatory processes across the sector.
- Ensure that the site maintain the required licenses to operate, including compliance with the GDUFA requirements.
- Act as the liaison with the regulatory agencies and customers for all matters related to company’s regulatory submissions for the assigned products and for the site.
- Participate in customer audits and regulatory inspection, and support preparation of responses as necessary.
- Coordinate the work of other regulatory personnel, and act as mentor/coach/trainer within the Regulatory Affairs Organization and across the organization.
- Monitor the site regulatory affairs activities to ensure that they are aligned with the sector initiatives.
Qualifications for the Regulatory Affairs Manager include:
- BS in Chemistry or related science with at least 5-10 years related experience in the pharmaceutical or API manufacturing industry
- OR a Master’s degree in Chemistry or related science with 3-5 years related experience. Preferably a degree in Regulatory Affairs.
- At least 3-5 years’ experience in Regulatory Affairs, within the pharmaceutical or API industries.
- Experience engaging with Board of Health regulatory authorities for issue resolution is a plus.
- Working Knowledge of Trackwise® and Extedo® is a plus.
- Experience compiling DMFs, CEPs, and other international regulatory submission
- Experience in drug product submissions (ANDAs, INDs, NDAs, BLAs)
- Knowledge of processes for DMF submissions in US/Europe
- Good knowledge of API regulations, including but not limited to ICH Q7, Q10, Q11, and Q12, FDA and EMA regulations, etc.
Compensation for the Regulatory Affairs Manager include:
· $135,000 - $145,000 plus a 15-20% bonus
· Full benefits/Pension