Project Lead - Regulatory Submissions
CK Group is recruiting for a Project Lead within Regulatory Submissions to join a company in the healthcare industry at their site based in Stockley Park on a contract basis for 8 months and has a daily rate of £395 LTD.
The Company: As a global healthcare company, our client takes 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.
The Location: Stockley Park was the UKs first and most successful business park. Situated close to Heathrow Airport in West London, it is home to 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.
The Role: The job holder works with the GRL/Regional Rep (TG) or C&EP equivalent to ensure that appropriate content for a range of submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with company process and policy as they apply to the role.
- Accountable to GRL/Regional Rep/C&EP lead for delivery of submissions or strategy components for an assigned product in development or marketed product; planning own and submission team activities to ensure delivery to agreed timeframes and appropriate content.
- Responsible for the implementation of the submission strategy for TG supported markets.
- Responsible for the development and implementation of the submission strategy for NCE Global Delivery supported markets.
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.
- Works with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
- May be part of the Regulatory Matrix Team for the given product and accountable for leadership of relevant submission team.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc.
Your Background: To be considered you should have:
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/ EMAP Regulatory submission experience
- Knowledge of regulatory agency guidelines and expectations for submissions.
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines and managing multiple submissions simultaneously.
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
- Ability to interpret and advise on guidelines and requirements on a global basis.
- Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
- Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
- Proven ability to think flexibly in order to meet constantly shifting priorities and timelines.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email email@example.com. Alternatively, please click on the link below to apply online now. 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 46923 in all correspondence.