Head of CRA Labelling

Head of CRA Labelling, Up to £100k, Hertfordshire

We are now searching with one of global clients to secure a new Head of CRA Labelling in Hertfordshire.

This new opportunity will be based in leafy Hertfordshire, close to shopping centres, fabulous restaurants and the airport.

This role is very much engaged with the new entity coming out of our client's merger, so it will require the implementation of a re-structuring programme and therefore the successful Candidate will be the person who can demonstrate an excellent record in people management. The right Candidate will be someone who is both a Labelling Subject Matter Expert and an experienced People Manager.

The duties and responsibilities will include but not limited too:

• Provide leadership to the Central Regulatory Affairs (CRA) Labelling Team, and support labelling activities for EU and non-Eu regions for Marketing Authorisation Application and subsequent lifecycle management, and any other labelling activities as required by company strategy.
• Support the Head of Labelling and Regional Support - Europe by providing specialist regional labelling knowledge and skills to develop and lead departmental initiatives and roll-out Regional or Global initiatives.  
• Lead CRA Labelling Teams across multiple locations. Set objectives, conduct mid-year and end-year reviews, and ensure training, development and coaching of team members in order that they meet the team and individual objectives.  
• Ensure Product Information texts for procedures managed by CRA are prepared to a high standard and on-time according to agreed company procedures and objectives. Support team members by reviewing texts intended for submission and advise Senior Management regarding any deficiencies or issues.  
• Represent the CRA Labelling teams during internal or external inspections and audits.  

The successful individual will be managing 3 sites, 2 in the UK, 1 in Germany. There are changes coming, both cultural and behavioural requiring strong leadership in order to manage the collaborative working of these sites.

 Here are the minimum qualifications and essential functions for this position:  

• Minimum of a Bachelor of Science Degree.
• At least 15 years’ experience in the Pharmaceutical Industry preferably within a Regulatory, Product Safety and/or Labelling environment. However, a combination of experience and/or education will be taken into consideration.
• Must have at least 5 years functional management experience.
• Strong communication skills with broad business awareness and the ability to interact at all levels of the organization.
• Must be able to read, analyze and interpret regulatory, manufacturing & compliance documents, artwork, common scientific and technical journals.

If you are interested in this position, please do get in touch




The candidate must have the rights to work in the location stated in the job advert.

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