Thermo Fisher Scientific Sr Manager of Regulatory Affairs in South San Francisco, California

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

The scope of this position holds responsibility for directing the applied content team in the education and awareness of Thermo Fisher Scientific internal and external customers on the clinical utility of our existing Genetic Science Division applied content. This position ensures the appropriate dissemination of clinical and scientific information regarding marketed and pipeline products in a timely, ethical, regulatory compliant and customer-focused manner.

Sr Manager of Regulatory Affairs will coordinate the applied content efforts of the of Sales, Marketing, Business Development and Technical R&D/ support services. Working with internal and external customers include targeted health care administrators, clinicians, laboratorians and other appropriate ancillary health care professionals as well as our sales/marketing teams, distributors and license partners. The position requires a high degree of flexibility with the ability to work both independently and as a part of a team. One should exhibit excellent problem solving skills and the ability to create success by professionally presenting the Thermo Fisher Scientific message to both individuals and groups.

What will you do?

  • Supports and facilitates the applied content team processes both internally and cross functionally in the development of key opinion leaders, product champions, research opportunities and advocacy for Thermo Fisher Scientific products at key accounts and national organizations.

  • Collaborate with the senior commercial manager and local sales representatives to appropriately manage educational needs and assist in the identification of key accounts. In efforts to maximize the benefits of education during all phases of the sales cycle, education priorities should be established with potential, new and existing accounts.

  • Coordinate and Assist Sales on a national level in strategies and tactics throughout product implementation with ongoing education in key accounts to ensure correct technique is maintained and that the medical/lab staff understands the clinical utility of the marker(s).

  • During field travel, assist in the coaching and clinical training of the applied content team, sales executives and clinical representatives through curriculum development, individual training and group instruction.

  • Understand administrative reporting responsibilities and maintain accurate and timely reports.

  • Submit accurate and timely expense reports while adhering to all corporate guidelines.

  • Attend and participate in professional meetings.

  • Communicate to peers new advances or changing trends identified in the healthcare marketplace.

  • Continually educates self on global market issues / trends and product knowledge as it pertains to specific business responsibilities in key therapeutic areas.

  • Creates a learning environment, open to suggestions and experimentation for improvement

  • Leads by example to embraces the ideas of others, nurtures innovation and manages innovation to reality

How will you get here?


  • 4-year Bachelor’s Degree from an accredited college or university is required. (Nursing Associate degree with accompanying RN certification from an accredited program may be acceptable with non-nursing bachelor degree) MS is preferred, MBA a plus.


  • 10 years of management or supervisory experience preferred.

  • Previous clinical and healthcare industry experience in Medical Affairs preferred.

  • Laboratory diagnostics familiarity/experience preferred.

Physical Requirements:

  • Normal office environment.

  • Position may require frequent communication and walking to other areas in which designated PPE will be required.

  • Position will require sitting and standing.

  • Employee may occasionally lift and/or move up to 10 pounds.

Non-Negotiable Key Tasks and Position Criteria:

  • The job requires 3 to 4 days of travel per week that may include multiple overnights (2 to 3 overnights per week).

  • Strong scientific/clinical baseline knowledge and experience.

  • Knowledge of clinical trial methods, implementation and interpretation; possesses sound scientific and clinical judgement; and able to work in various disease entities

  • Strong compliance knowledge and adhere to corporate compliance in all activities - including those related to clinical trials, scientific presentations, and responses to unsolicited requests for information

  • Outstanding verbal and written communication skills

  • Working knowledge of Microsoft Office

  • Strong customer-facing skills; listening skills; probing skills; and flexibility

  • Excellent cross-functional collaboration skills and experienced in working with colleagues and teams across key disciplines

  • Develop and maintain local relationships with critical thought leaders and reference accounts.

At Thermo Fisher Scientific, each one of our 65,000 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!

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.