Regulatory Affairs Manager (M/F)

  • Company : Alliance Consulting
  • Localisation : Hertfordshire, St. Albans - Midlands de l'Est, Royaume-Uni
  • Position : Regulatory Affairs Manager
  • Type of Contract : Permanent contract
  • Date of publication : 2018-02-05
  • Apply

Job Description

Regulatory Affairs Manager (Pharmaceuticals)

Location: North London

Salary: £35-65,000 plus benefits

Regulatory Affairs

We are a successful and expanding pharmaceutical company. Due to this, we now have a requirement for an experienced Regulatory manager with experience in submissions of MA variations within the MENA and ROW. You will be leading the Regulatory function of the business and develop systems for the future. We are only able to accept applications from experienced Regulatory Managers with experience of MA variations within the MENA and ROW.

Regulatory Affairs Manager (Pharmaceuticals)


  • Development and submission of MA variations, renewal documents, post marketing commitment submissions of MA\'s in MENA region and ROW.
  • Building and managing external partners
  • Managing/supporting a range of changing project demands
  • Advising on New product development
  • Gap analysis of regulatory documentation. Identifying possible challenges and propose suitable solutions.
  • Maintain a strong relationship with regulatory authorities. To allow for an effective working relationship.
  • Regulatory submissions and commitments are updated and maintained.
  • Enable and ensure all processes are carried out according to guidelines and SOPs.

Required Skills:

  • Bachelor\'s degree equivalent or higher qualification within Pharmaceutical or relevant life science
  • 5+ years\' experience within Regulatory affairs
  • In-depth knowledge of MHRA, EMA and MENA regulations
  • Ability to multitask and react quickly to changing situations
  • Excellent verbal and written communication skills
  • Experience working with government agencies and trade organisations
  • 5 - 10 years\' regulatory experience

When applying for this role, please indicate your current salary (plus benefits package), minimum salary required, notice period and your reasons for wishing to move from your current company. Alliance Consulting is acting as an employment agency in this respect. Alliance Consulting specialise in the placement of engineers throughout the UK. By sending us your CV you are explicitly consenting to our processing of your personal data on a computer database and/or in manual files for the purpose of evaluating your application for employment. This processing will be carried out in accordance with the UK Data Protection Act 1998. By applying for this role you hereby consent to us submitting your CV to our client. If you do not wish your CV to be sent to our client then you must clearly state this to us. Equally, if there are any companies that you do not wish your CV to be sent to (for whatever reason), then please let us know of this when you apply.

Required profile

regulatory affairs, MENA, MAs, pharmacovigilance, labelling, submissions, gap analysis, registration, SOPs,
  • Start date : ASAP
  • Term :
  • Experience Required : 5 to 10 years
  • Salary : £35000 - £65000 per annum
  • References : 886505GH_1517823936
  • Activity area : Quality

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