Regulatory Affairs Specialist I

4 months ago

Basingstoke, United Kingdom Thermo Fisher Scientific Full time

Business Job Title: Regulatory Specialist

Job Profile Title: Regulatory Specialist, I

Direct Report To: Senior Regulatory Manager or RA Supervisor or Regulatory Specialist, II or Regulatory Specialist, III

Group/ Division: Microbiology Division (MBD)

Career Band: 4

Career Track: Professional

Position Location: Basingstoke

Number of Direct Reports: 0
- About Thermo Fisher Scientific:
Joining the Thermo Fisher Scientific you will be a member of a team that values performance, quality and innovation. As part of a growing global organization, you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Working within our MBD, within the Specialty Diagnostics Group(SDG), you’ll play an active part in helping us to achieve our mission to enable our customers to make the world healthier, cleaner and safer. The Microbiology Division discovers microbiological solutions for the diagnosis of infectious disease and detection of bacterial contamination. We serve public health, clinical laboratories, food companies, environmental screening and pharmaceutical laboratories with a portfolio of products that include culture media, antimicrobial susceptibility testing solutions and best-in-class molecular solutions for food safety testing.

This is a divisional role in MBD Global RA function. This role will assist the wider RA team for the regulatory aspects of the full life cycle of MBD’s products.The primary purpose of this role is work within the Market access regulatory affairs team and to assist in the management of regulatory submissions in rest of the world markets, product changes, notification of such changes to global regulatory agencies and product life cycle management activities.

The main interfaces for this role include Commercial, Operations, R&D, Product Management, QA, ROW competent authorities, Regional RA Team, Product RA and EU RA team.

**Responsibilities**:

- Product lifecycle management, from initial registration through to discontinuation in RoW markets
- Review and maintain regulatory submissions, for completeness and quality in RoW markets
- Timely review of change requests, identification of significant changes and impact on existing licenses. Supporting the Operation, Sourcing and Purchasing teams for the successful completion of engineering change activities.
- Processing of customer services and commercial enquiries in relation to products classifications and regulatory status in ROW markets. Working in a concise and timely manner to prevent customer impact.
- Work collaboratively with Product RA to gain and obtain pre-market licenses globally for the product groups in the MDSAP markets
- Develop and maintain external relationships with key regulatory officials and commercial partners in all applicable territories.
- Support the Quality Assurance team during notified body, customer and competent authority audits. Ensuring we are audit ready.
- Assist to deliver the plan agreed in RoW markets to make sure that we stay in compliance.
- Regularly update all trackers to report accurately on project status
- Participate and lead meetings and share any meeting minutes and actions with the Senior Team
- Keep abreast with regulatory IVD landscape and Regulatory Intelligence in RoW markets
- Understanding impact of Regulatory Intelligence on MBD portfolio of products
- Experience, skills & abilities required:
1. A strong sense of customer service and ability to work with a broad range of Customers and within the matrix structure of our organization.

2. Consistently demonstrates our 4i Values of Integrity, Intensity, Innovation & Involvement.

3. Puts the Customer First.

4. Thinks and acts with a customer-centric demeanour to deliver exceptional customer experience.

5. Continuously improves internal processes to build value for the customer.

6. Develops and maintains successful customer relationships (internal and/or external).

7. Owns Their Results.

8. Takes personal accountability for decisions and actions, and always exercises good judgement.

9. Takes personal ownership for adherence to safety, compliance, quality, and cyber security.

10. Consistently applies good judgement and maintains dedication to Thermo Fisher Scientific ethics and values.

11. Finds a Better Way Every Day.

12. Is intellectually curious and embraces continuous improvement, challenging the status quo.

13. Introduces and proactively seeks out new insights and solutions to strengthen performance.

14. Ensures standard processes and lessons learned are adopted.
- Minimum Requirements/Qualifications:
Excellent oral and written communication skills.

Ability to work both independently and as a team member.

Strong attention to detail, quality background and problem analysis and decision-making skills.

Self-starter who can take general concepts and direct

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