European Regulatory Affairs General Medicine

CK Group are recruiting for a European Regulatory Affairs Senior Manager to join a biopharmaceutical company, who are based in Uxbridge and Cambridge on a contract basis for 12 months. This role is inside IR35, and allows for Remote working.
**Rates**:
Hourly: Up to £70.00 Umbrella / £50.00 PAYE
**Company**:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human geneticsto unravel the complexities of disease and understand the fundamentals of human biology.
**Location**:
The role is remote based position but the office team location is Uxbridge and Cambridge. Ideally you should be able to travel into the office occasionally for meetings.
**European Regulatory Affairs General Medicine Therapeutic Area Sr. Manager**:
This role will provide regional regulatory support for one or more products. As a member of the Global Regulatory Team (GRT), the incumbent will be accountable for developing and executing regional regulatory strategies across the product lifecycle and managingeffective agency interactions. The individual should have a proven track record supporting the diversity of regulatory procedures in the EU (inc. PIPs, variations, IMPDs, MAAs) and ability to work autonomously.
The purpose of this role is to progress the Amgen pipeline through timely regulatory approvals, including clinical trials for investigational medicinal products, as well as approved medicinal products, and to ensure timely regulatory compliance with such approvals.

**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
- Leads development of regional regulatory documents and meetings, and provides regulatory advice on regional regulatory requirements, mechanisms to optimize 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 to products, 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 interactions

**Key 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

**Preferred Requirements**:

- Experience of working directly with the EMA and Centralised Procedure
- Experience in Inflammation, Cardiovascular, Bone, Therapeutic Area
- Experience working with biotechnology products

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote reference 54491 in all correspondence.