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.
- This position will provide strategic and tactical support to the cell & gene ancillary and reagent core 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 support the Cell & Gene Therapy business through utilization of our CTS (Cell Therapy Systems) branded product.
- This position will lead a team and provide strategy guidance and support.
What will you do?
- 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
- 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 core team lead and provide active and ongoing regulatory guidance to project teams
- Document regulatory strategies for product submissions.
- Facilitate and prepare U.S. regulatory Pre Submission or submission documents
- Lead FDA pre submission and submission meetings
- Support and guide team members through submission.
- Support global regulatory registration representatives for product global registration activities
- Perform regulatory assessment of new and changed products.
- 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 8-10 years Regulatory Affairs experience in Pharmaceutical, Biologics or Medical Device
- This experience must include either BLA, 510(k), PMA, 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 core 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 IVD reagent chemistry, laboratory automation, and software components of 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
To Apply, please click the following link: https://thermofisher.contacthr.com/82394969
Apply on company website