Regulatory Affairs Director CGT

Job description

Thermo Fisher Scientific Inc.

is the world leader in serving science, with annual revenue exceeding $40 billion.

Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them.

Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.

thermofisher.com.





**Group/Division Summary:**



You will work within exciting area of Cell & Gene Therapy (CGT) business in the Life Science and Laboratory Products Group (LSLPG).

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.





**Position Summary:**



You will partner with the CGT business by establishing and implementing global regulatory strategies.



You will lead the CGT Regulatory team and build on the team as the business evolves.





You will report to Sr. RA Director of LSLPG.





**Key Responsibilities:**



As leader of the CGT RA team, this position defines regulatory strategy for the Div./ BU and provide visibility in driving industry standards for CGT products developed by Thermo Fisher Scientific.





Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and completed per regulatory and business requirements.

In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution.





+ Responsible for organizing and developing CGT RA team to support the business goals

+ Develop and retain RA talent

+ Provide strategic regulatory guidance 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

+ 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 positive changes in customer experience

+ Provide counsel and guidance to customers using our products in their regulatory submissions

+ Keep tabs on new or revised regulations, guidelines

+ Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment

+ Support Regulatory department in the update, enhancement, and creation of internal policies and procedures

+ Participate in business meetings with potential new external partners



**Qualifications:**



Education



+ A minimum of B.Sc.

degree in Biology, Chemistry, bio-engineering or related science.



Experience:



+ Must have a minimum of 10 years’ experience in Pharmaceutical, Biologics or Medical Device with 7 years in regulatory affairs.

Experience in biologics is preferred

+ This experience must include either Biologic, Pharmaceutical or Medical Device (510(k), CE IVD) submissions.

Prior CGT experience is helpful.

Must be well versed in the aspects of regulatory strategy creation, submissions, 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

+ Regulatory review of promotional marketing materials, press releases, labeling, etc.



Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Watch as our colleagues explain 5 reasons to work with us.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.



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.





Accessibility/Disability Access



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Please include your contact information and specific details about your required accommodation to support you during the job application process.





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Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.



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.

Required Skill Profession

Other General