Regulatory Affairs Manager

Posted 30 August by CK GROUP
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Amy Lloyd at CK Clinical is recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in Hertfordshire on a permanent basis.

The Company:
Our client is a fast growing privately owned pharmaceutical company, providing EU market analysis, launch planning and commercialisation for pharmaceutical manufacturers and distributors. The leadership team has a combined 50 years of successful planning, marketing and sales of brands and generics. Our client provides the NHS with a range of its own products as well as assisting in the distribution of other products on behalf of partner companies.

The Location:
Our client is based in the market town of Ware, Hertfordshire. Access is easy with Luton and Stansted airports being 45 mins and 30 mins by car, respectively. The base is 2 minutes' walk from Ware station, with frequent trains to London's Liverpool St station.

The Role:
- Ensure that new marketing authorisations (MAAs) are secured according to the needs of the UK and Irish business.
- Ensure that existing marketing authorisations are maintained according to relevant regulatory requirements and business priorities.
- Provide regulatory direction and support to product launch and commercialisation activities including artwork, labelling etc.
- Ensure that registration applications and deliverables are of a high standard, aligned with business priorities and that there is timely strategic input and consideration for UK and Ireland needs to development and regulatory plans for pipeline assets.
- Provide regulatory advice and support in the investigation of new business opportunities in UK/Ireland.
- Regulatory contact point as required for 3rd party companies where UK/Ireland companies are distributors.
- Ensure the company is being regarded as a competent partner with the relevant competent authorities in the UK and Ireland.
- Facilitate timely surveillance of relevant legislation as well as other public regulatory information and ensure relevant dissemination and action to ensure compliance and/or competitive advantage.
- Maintain and extend solid relationships with UK MHRA and Irish HPRA to support UK/Ireland and European RA matters smoothly.

Your Background:
- Educated to degree level (Bachelors or Masters) in a relevant discipline.
- A proven regulatory strategist with a successful track record of ensuring business success in an affiliate position and specifically within UK and Ireland.
- Established credibility with regulatory agencies with excellent negotiation skills and demonstrable success in influencing HA positions to ensure positive regulatory outcomes.
- Track record of overseeing quality regulatory submissions and approvals with UK and Irish HAs.
- Strong leadership skills with both practical and short/long term strategic vision; ability to build relationships and inspire confidence and respect at all levels; excellent team player.
- Outstanding communication skills.
- Ability to build rapport and demonstrate strong influencing and negotiation skills.
- Excellent listening ability - receptive to feedback and demonstrates flexibility, curiosity and an ability to learn.

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 46433 in all correspondence.

Reference: 38800639

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