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Job Details

Regulatory Affairs CMC Manager / South-East / Join a Biologics company with a Great Pipeline

Company: Advanced Regulatory (UK & Europe)
Location: South-East, with options to work 2 days from home
Reference: TMADV /260716C
Closing Date: 09 Jan 17
Type: Full Time
Salary (£): On Application
Benefits: On Application

Job Summary:

We have a new role based in the South-East for a Top Ten Biotechnology company who require a CMC Regulatory Affairs Manager to cover development, registration and approval/post approval activities. This is varied and highly strategic CMC at a Global Head office. Contact Theo Moore on +44(0)207 801 3384 to apply for this role or send your CV in confidence to CV@advregulatory.com.

Requirements:

Regulatory Affairs CMC Manager / South-East / Join a Biologics company with a Great Pipeline

Location: South-East Greater London

My client is a top ten highly rated and extremely successful Biopharmaceutical company with a Global reach and they are seeking a Regulatory Affairs CMC Manager for a role covering CMC regulatory strategies for assigned projects which cover both development and marketed activities.

This is a dynamic, international and expanding UK based pharmaceutical client company that has created a culture that nurtures autonomy and creative thinking and provides opportunities for individuals to excel in a collaborative, team-based environment. Their entrepreneurial mind-set fosters diverse perspectives and drives their passion for impact.

Role:

  • You will be focused on bring technical expertise, creativity and innovation as you maximize the business benefits balanced with regulatory compliance.
  • Co-ordinate and drive global regulatory strategy for complex submissions and determine and drive the execution of regional CMC regulatory plans in line with the global regulatory strategy.
  • Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Regulatory CMC, Drug Regulatory Affairs (DRA).
  • Initiate and lead regional Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals.
  • Provide leadership within the department through specialised matrix functions and by utilizing CMC regulatory expertise to drive improvements.
  • Represent Regulatory CMC at Global Supply Support Teams.

Salary/Package:

  • Salary to £75,000
  • Full private healthcare and pension
  • Bonus paid once a year and a car or car allowance
  • A full re-location available

Experience needed:

  • 3-10 years in Regulatory Affairs
  • Knowledge of EU MAA’s & CMC dossier build
  • Knowledge of HA negotiation
  • Project/portfolio management experience
  • Strong leadership, negotiation and communication skills

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If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.
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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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