Senior Manager Regulatory Affairs

Quanta part of QCS Staffing; Cambridge; On-site; GBP 60,000 - 85,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Manager in Regulatory Affairs to define and implement regulatory strategies. The role involves significant interaction with stakeholders and regulatory bodies, ensuring compliance and guiding product submissions, crucial for enhancing patient outcomes. Candidates should have strong regulatory experience in a relevant therapeutic area and knowledge of European legislative frameworks.

Qualifications

• Experience as therapeutic area European Regulatory Affairs lead.
• Regulatory knowledge of regional legislation and policies.
• Experience working with the EMA and national regulations.

Responsibilities

• Define and advise on regulatory strategy for product submissions.
• Manage regulatory documents and ensure alignment with stakeholders.
• Maintain awareness of regulatory changes and impact on projects.

Skills

Regulatory strategy

Regulatory compliance

Drug development

Legislation knowledge

Relationship management

Job description

Social network you want to login/join with:

Senior Manager Regulatory Affairs, Cambridge

col-narrow-left

Client:

Quanta part of QCS Staffing

Location:

Cambridge, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

982ce4852d4a

Job Views:

4

Posted:

02.06.2025

Expiry Date:

17.07.2025

col-wide

Job Description:

Senior Manager Regulatory Affairs - Pharmaceuticals -Cambridge

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Manager Regulatory Affairs. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.


Responsibilities:

Define and advise the GRT on regional considerations in developing creative regulatory strategy

Ensures European regional needs are well defined and implemented in collaboration with relevant regional stakeholders

Develops and implements regulatory strategy and executional plans, and manages regulatory submissions (e.g., clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and regulatory requirements

Leads development of regional regulatory documents and meetings, and provides regulatory advice on regional regulatory requirements, mechanisms to optimise product development and to maintain compliance

Co-ordinates and provides guidance to company responses to requests from regulatory authorities, e.g., Response to Questions (RTQs)

Communicates and ensures alignment with proposed regulatory strategies such that expectations, regulatory risks, and mitigations are characterised and understood.

Estimate the likelihood of regulatory success and timelines based on proposed strategies; discuss with GRT and line Management, and communicates to stakeholders

Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating toproducts, and evaluates and communicates impact

Act as contact and create relationships with agency staff on specific product assignment and document and communicate details and outcomes of regulatory agency interaction.

Basic Requirements:

Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans

Practical Regulatory knowledge of regional legislation

Working with policies, procedures, and SOPs

Experience with national legislation and regional regulations relating to medicinal products

Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions, and renewals

Understanding of drug development

Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage

Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes

Experience of working directly with the EMA and Centralised Procedure

Experience in Inflammation, Cardiovascular, Bone, Therapeutic Area

Experience working with biotechnology products

If this role is of interest to you, please apply now!


#LI-KT1