CK Group is recruiting for four Senior Regulatory Executives to join a company in the Pharmaceutical industry at their site based in Uxbridge on a 9 month contract basis initially.
As a global healthcare company, they take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
Stockley Park was the UK's first and most successful business park. Situated close to Heathrow Airport in West London, it is home for roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport a few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the park.
· Preparation of high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources. liaising closely with other company personnel to ensure accuracy of such records.
· Working to agreed deadlines and maintaining records to reflecting project status
· Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice
· CMC experience
· Good written and oral communication and networking skills
· Demonstrate ability to focus and work with attention to detail
· Demonstrate ability to retain critical information
· Be aware of the contents of a marketing authorisation application
· Demonstrate team working and effective time management skills
· Be a dynamic and highly motivated individual
· Establish strong relationships and liaise effectively with company sites worldwide
· Be proficient in the use of IT packages such as Word and excel.
· Demonstrate problem solving skills
· Post Approval CMC experience preferential
· CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations
· Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
· Experience responding to manufacturing site change controls and providing regulatory advice and strategies
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 45466 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Julie Marshall
- Phone: 01438 723 500
- Reference: 45466
- Posted: 8th May 2019
- Expires: 5th June 2019