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Regulatory Affairs Specialist III

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Regulatory Affairs Specialist III

Oslo, Norway

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

We are currently seeking a Regulatory Affairs (RA) Specialist to join Biosciences Division Regulatory Affairs Team. As a member of the RA team, you will be planning, managing, and tracking of regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies.

Key responsibilities:

  • Support of activities at Thermo Fisher Scientific site(s) located in Norway for the bead-based technology products and processes (part time).
  • Serving as the liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal.
  • Collecting, consolidating and ensuring accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets).
  • Creating and maintaining up to date product technical documentation - Master Files.
  • Reviewing and approving product labeling and marketing information to assure compliance with the applicable requirements.
  • Providing regulatory support and expertise to new product introduction project teams and different departments.
  • Participating in change control activities by evaluating impact of manufacturing changes on technical documentation and submitting updates to the competent authorities.
  • Developing regulatory affairs internal policies and procedures and providing trainings as and when required.
  • Appropriately handling confidential information.

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Requirements for qualification / education / experience:

  • University degree in life sciences.
  • Familiar with global Health Authority regulations/guidances eg. FDA regulations, ICH and EMA guidelines/directives. Understanding of QMS standards (e.g. ISO 9001, ISO 13485) and GMP requirements.
  • Experience in the field of regulatory affairs and/or in the pharmaceutical or medical device manufacturing company for over 3 years.
  • Abilities to plan, prioritize and coordinate working process independently and with minimal direction.
  • Proficiency with computer programs/systems (MS office, etc.) with demonstration. Ability to learn new systems quickly.
  • Strong analytical skills and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams.
  • Willingness to travel 2-10% of time.

We offer:

  • The innovative environment of the rapidly growing international company with encouraging working culture and outstanding development possibilities to increase your potential.
  • An opportunity to work in a dynamic global organization and collaborate with expert professionals.

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

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

Compensation
The monthly salary range estimated for this position based in Lithuania is €2 625,00-€3 500,00.

Client-provided location(s): Oslo, Norway
Job ID: ThermoFisher-R-01265501_1001-5
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program