Regulatory Affairs Manager - Uxbridge or Cambridge

27 Nov 2018
25 Dec 2018
Regulatory Affairs
Contract Type
Lucy Stendall at CK Group is recruiting for a Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in Uxbridge or Cambridge on a contract basis for 12 months initially.

The 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 genetics to unravel the complexities of disease and understand the fundamentals of human biology.

The Location:
Located less than an hour away from London by train, the role will be based in Cambridge or Stockley Park.

Cambridge is one of Britain's most beautiful cities. Our client first established a presence on the Cambridge Science Park more than 25 years ago. Today, Cambridge still remains at the forefront of science and is one of Europe's most important biotechnology clusters.

Stockley Park was the UK's first and most successful business park. It has excellent transport links with the M4 and M25 motorways and Heathrow Airport few minutes away and a choice of railway and tube stations and extensive bus networks.

The Role:
This role will support one or more products from a regional (extended Europe) regulatory perspective. The Regulatory Affairs Manager will ensure that the company acquires and maintains all the required licenses in order to support clinical trials and further development of investigational medicinal products; market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety.

Responsibilities include:
Strategy and Execution
• Plans and manages regulatory submissions for products within the company portfolio in compliance with global filing plans and local regulatory requirements.
• Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Provides content guidance for regional regulatory documents and meetings in accordance with global strategy.
• Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans).
• Supports regional label negotiation activities.
• Under general supervision participate in the development, and execution of regional regulatory product strategies.
• Ensures regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders.
• Communicates regulatory strategies within team.
• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
• Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to company products.
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product development.
• Under supervision evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.

Your Background:
To be considered for this role you should have the following knowledge, experience and skills:
• Scientific Degree and demonstrated experience in a similar role.
• Regulatory principles: (Working with policies, procedures and SOP's, Knowledge of legislation and regulations relating to medicinal products, Awareness of the registration procedures in region for development, MA, post approval changes, extensions and renewals.
• Knowledge of drug development.
• Knowledge of and experience in regional regulatory environment.
• Team work.
• Communication skills - both oral and written.
• Ability to understand and communicate scientific/clinical information.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44047 in all correspondence.

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