FSP Regulatory Affairs Specialist - CMC Compliance Officer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our collaborative team as a Regulatory Affairs Specialist I at Thermo Fisher Scientific, where you'll contribute to ensuring our products meet global regulatory requirements and help make the world healthier, cleaner, and safer. You'll work with cross-functional teams to manage product registrations, maintain compliance documentation, and support regulatory submissions across international markets. This position offers excellent professional development opportunities within our innovative environment focused on serving science.

As a valuable member of our Regulatory Affairs team, you'll compile technical documentation, review regulatory requirements, and support product lifecycle management from initial registration through post-market activities. You'll collaborate with Quality Assurance, R&D, Commercial teams, and regulatory authorities to ensure compliance while facilitating efficient product launches and maintaining existing approvals.

PURPOSE OF THE FUNCTION

Facilitates activities related to Compliance within TechOps team, in close collaboration with Product Quality and External Manufacturing network.

Ensures cross-functional alignment for critical Compliance topics and projects.

Keeps dashboards and compliance operations on track and resolves potential issues that may impact the timely assessment and closure of actions.

The role requires strong sense of ownership, excellent communication and coordination skills in partnership with internal and external partners to ensure accuracy and timely deliverables.

ROLES AND RESPONSIBILITIES

Change Control management:

• Maintain a CC tracker, liaise across functions to follow status, monitor & coordinate implementation dates with CMOs, facilitate cross-functional meetings, makes sure change actions are completed on time (KPIs dashboard), coordinate with Supply plans for impacted post-change batches, alignment on multi-asset changes per Site in close collaboration with Quality
• Manage the Change Control Review Board.

Deviations management:

• Establish and maintain Deviations tracker, liaise with CMOs to pursue critical deviations actions.
• In partnership with Quality, build a system allowing adequate Deviation management.

Annual Reports:

• Annually for each asset (commercial & development), extract applicable list of CC implemented during the reporting period per jurisdiction, facilitate interactions & alignment across functions in the context of annual report drafting and review.

Health Authority Commitments:

• Maintain a Commitments tracker per Asset and map timelines
• coordination of actions and technical activities, make sure studies are initiated in time to generate data for submission, as needed.
• Tracking the execution of regulatory Commitments in close collaboration with Reg CMC team for each Asset.

Compliance of Excipients:

• Coordinate choice of material /supplier for manufacture of batches in compliance with regional country Pharmacopoeia requirements /or changes triggered by compendial updates
• Tracking execution of regulatory Commitments and preparing regular dashboards

REQUIREMENTS:
• Degree in biotechnology, pharmaceutical sciences or bioengineering

• Relevant expertise in CMC Project Management or Quality & Compliance background, or a similar role within the Biotech industry.

• Additional qualifications in Quality Management or Regulatory Affairs advantageous
• Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)
• Experience with regulatory submissions and documentation management
• Strong technical writing and documentation skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and preferably with document management systems
• Excellent organizational abilities and attention to detail
• Strong analytical and problem-solving capabilities
• Effective verbal and written communication skills in English
• Ability to work both independently and collaboratively in a matrix environment
• Experience with regulatory databases and submission systems preferred
• Knowledge of GMP, ISO 13485, and quality management systems
• Ability to manage multiple projects and meet deadlines
• Customer-focused mindset with strong interpersonal skills
• Demonstrates company values of Integrity, Intensity, Innovation, and Involvement

• Team player; able to build effective relationships with internal and external stakeholders.
• Leadership and communication skills

• Experience in operations, planning, project management, and tracking projects with high complexity and risk, including clearly defined critical paths.
• Experience managing projects across global locations and time zones, as well as working effectively in diverse cultural and international environments.

• Well organized and able to handle multiple assignments in parallel.
• Eye for detail and quality conscious attitude.
• Proactive – can do mentality.