Regulatory Manager in Kent or Surrey

Recruiter
CK Clinical
Location
Kent
Posted
12 Oct 2018
Closes
17 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Natasha Young at CK Group is recruiting for a Senior Regulatory Manager to join a company in the Pharmaceutical industry at their site based in Sandwich on a 12 month contract basis. This role can also be based in the Surrey area with once weekly trips to Sandwich. The successful candidate will be joining the Submissions Management team in Worldwide Safety & Regulatory.Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.The Role:The Senior Regulatory Manager will oversee the compilation of the Investigator's Brochure (IB) and is responsible for the proactive end-to-end project management of the IB within agreed timelines and in accordance with ICH guidelines. Key responsibilities include: · Chair IB kick off meetings, leading IB discussion whilst utilizing IB expertise to support the team in updating an IB within the required timeframe. · Acts as an end to end project manager for IBs. Responsible for IB compilation of distinct sections into a cohesive document fit for submission purpose. · Prepares deliverables in accordance with SOPs, regulatory guidance and internal job aides.· Closely monitors project timelines associated with specified documents and tables and ensures delivery of necessary contributions according to timelines. · Escalates compliance risks and proposes solutions.· Ensures Compliance of IB updates with ICH requirements. Interprets current and new ICH and external regulatory requirements. Proposes function implementation of new emerging ICH guidance/regulations and provides impact assessments.· Ensures that IBs are notified to Alliance Partners (AP), as appropriate, so that distribution to end customers occurs in line with business expectations. Monitors internal process and CTPQS alignment of AP IB distribution. Challenges metrics and delivery dates of IBs to sites. Raises potential compliance risks to the BPO.· Ensures that corporate systems used to store and track IBs are maintained in real time. Leads system and process change. Highlights potential gaps, proposes solutions and leads implementation.· Leads Lessons Learned sessions and implements change. Drives communication and proposes refinements in the IB process and related projects through collaboration with stakeholders. Plays an active role representing IBs on cross functional teams. Your Background:To succeed in this role, you will have experience associated with the management of IBs and compilation. You will understand the core function and content of IBs. You will also have good experience of managing projects with a strong focus on quality and compliance. You will come from pharmaceutical background and be familiar with EU and FDA regulations. 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 KA43617 in all correspondence.

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