Thermo Fisher Scientific Director, Regulatory Affairs in Waltham, Massachusetts
How will you make an impact?
Thermo Fisher is seeking an experienced Regulatory Affairs professional to join the exciting area of cell and gene therapy applications. Main areas of focus include ancillary reagent, viral vectors, cell line development, and closed cell processing system designed for separation, washing and concentration of both autologous and small-scale allogeneic cell therapy samples and unintended excipients.
This position will provide strategic guidance to the global cell & gene therapy business and commercial teams.
The position will work in the Regulatory Affairs department and will establish and execute global regulatory strategies, lead FDA pre-submission package development and subsequent meetings and author final product submissions or assist customers with their BLAs and other global product submissions.
This Regulatory Affairs professional will partner with the Cell & Gene Therapy business through utilization of our CTS (Cell Therapy Systems) branded product by providing strategy guidance and support.
This position will lead the CGT Regulatory team and build on the team as the business evolves
What will you do?
Define Regulatory/ Clinical Strategy for the Div./ BU and provide visibility in driving industry standards for CGT tools
Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
People leader providing support and guidance across divisions and regions
Provide strategic regulatory support for business development
The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals.
Serve as the regulatory lead and provide active and ongoing regulatory guidance to project teams and direct reports.
Develop regulatory strategies for product submissions and guide team members through submission process.
Support global regulatory registration representatives for product global registration activities
Interact with local regulatory authorities and influence policy; globally
Interact with customers and implement tools and/or services: To drive step change in customer experience
Provide counsel and guidance to customers using our products in their regulatory submissions
Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
Participate in business meetings with potential new external partners
How will you get here?
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
Must have a minimum of 10 years’ experience in Pharmaceutical, Biologics or Medical Device with 5 years in regulatory affairs.
This experience must include either Biologic, Pharmaceutical or Medical Device (510(k), CE IVD) submissions. Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
Experience as the RA representative on project teams providing active and successful regulatory guidance and RA strategies.
Experienced people leader
Experience with business development
Experience in the balance and application of regulatory requirements
Direct and positive experience in communicating with Regulatory Authorities and co-development partners.
Regulatory review of promotional marketing materials, press releases, labeling, etc.
Demonstrate in-depth understanding of advanced technical/scientific principles related to reagent chemistry, laboratory automation, and software components in in-process and/or IVD medical devices.
Capacity to communicate regulations to technical functions within the company
Knowledge, Skills, Abilities
High energy level; positive attitude; works well under stress, Strong communicator and leader
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Ability to provide solutions based on knowledge of regulation and industry experience
Willingness to travel (10-15%)
Comfortable with ambiguity and change
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.
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