My client, a highly successful global pharmaceutical company, is looking for a Senior Regulatory Affairs Manager on an initial 12 month contract basis.
* Regional strategic exp UK & Switzerland, solid Regulatory EU centralised exp
* Proven Regional global team exp is a must
* Ideally have exp of leading MAA but not essential but a desire, sit with the Global Regulatory team as be able to advise them on the strategy.
* Be able to present options/Risks and be innovative and be advisory on the Regulatory environment. Need to be able to operate in this type of environment, quite a fast past place so need to be able to thrive in this operating environment. Mid to late development in Similar , early obesity area covering all stages, Some marketing products, clinical trial experience.
* Solid Regulatory Experience of 5/6 years' experience within General Medicine, someone who enjoys being a part of a Science and Innovation environment.
* Areas team cover:- Inflammation early to mid-development
Cardiovascular, Bone, therapeutic area is ideal
* Must have good leadership and communication skills.
* Understand about policies and SOP's and Amgen's procedures.
* Experience of working directly with the EMA and Centralised Procedure is important.
* Up to 6 years of this type of experience would be ideal.
* Someone with experience of working with biotechnology products is a desire.
Role Description: European Regulatory Affairs General Medicine therapeutic area Snr 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 managing effective 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.
* 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 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 Amgen 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
* 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 wit the EMA and Centralised Procedure
* Experience in Inflammation, Cardiovascular, Bone, therapeutic area
* Experience working with biotechnology products
If you believe you have a suitable profile please apply and get in touch with Ross Wilson for further infromation at email@example.com.
You must be eligible to work in the UK. Learn more
- Agency: Key People
- Reference: 25138
- Posted: 30th September 2020
- Expires: 28th October 2020