Job Title: Sr. Regulatory Affairs Specialist

Location: Cambridge, MA

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

Through supporting on-site inspections with regulatory authorities from around the world, participating in regulatory intelligence gathering, and partnering with VVS clients to ensure accurate and timely submissions the incumbent will help shape healthcare by improving patient access to novel therapeutics.

What will you do?

• Maintain VVS regulatory submissions (e.g. site master files and drug master files) and escalate potential risks during review and data verification processes to the applicable Quality and Operational Site Head and to the VVS Head of Quality Compliance and Regulatory Affairs

• Partner with customers and internal stake holders to provide the information necessary to support customer regulatory filings. Proactively work with VVS SMEs and responsible quality personnel to provide accurate and timely information supporting customer filings.

• Effectively communicate the status, objectives, risks, and mitigation plans associated with assigned regulatory projects and ensure program timelines are shared with appropriate SMEs within the organization.

• Support and coordinate responses to requests from regulatory authorities.

• Evaluate change controls for impact to approved client products and coordinate client communication with appropriate SMEs for VVS or client proposed changes.

• Evaluate, propose, and implement process improvement opportunities for Regulatory Affairs procedures.

How will you get here?

The incumbent will be provided with a comprehensive Regulatory Affairs training plan, appropriate procedures, work instructions, and access to experienced thought leaders in Regulatory Affairs through direct meetings with the Cambridge Manager of Regulatory Affairs, VVS Head of Quality Compliance and Regulatory, Global Regulatory community of practice meetings, and access to professional Regulatory Affairs organizations such as Biophorum and Parental Drug Association.

• 6+ years of Regulatory Affairs experience, preferably with major marketing application experience in biotechnology focused CDMO and a bachelor’s degree (life sciences preferable) OR
• 4+ years within an GMP Biotech or Pharmaceutical company with a master’s degree in Regulatory Affairs from an accredited College or University
• Minimally 4+ years’ experience working in Quality Assurance or as an SME with regulated sterile injectable drugs or biologics.
• Academic or working experience with regulatory processes and systems; preferred experience with CBER in US, CAN, EU and JP territories
• Experience successfully coordinating and navigating complex regulatory challenges

Knowledge, Skills, Abilities

• Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities

• Ability to positively motive and influence team members without line-management authority

• Excellent communication, analytical, and organizational skills, using modern technology platforms

• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.