Moin Din at CK Clinical is recruiting for a Head of Regulatory Affairs to join a leader in the manufacture and supply of speciality pharmaceuticals.
This Regulatory Affairs opportunity is a permanent role based in the South East UK.
This Head of Regulatory Affairs role is an amazing opportunity for the right person seeking their next career move. If you have solid experience in Regulatory affairs, especially in the ethical pharmaceuticals, devices arena and some experience of bio-tech products then please read on to find out more and apply.
Moin’s client joined the Sunday Times Deloitte Buyout Track 100, as one of the top 100 fastest growing private equity backed companies in 2012.
They are now looking to expand into new and exciting areas and are seeking a well versed and dynamic individual with great experience in Regulatory Affairs at a national, European and International level to take them to the next stage.
Reporting to the Medical Director, the Head of Regulatory Affairs leads the regulatory effort within the company in all territories the company operates throughout the world, providing focus and effective management to his/her team of eight regulatory professionals
The Head of Regulatory Affairs is responsible for training, planning, organisation of work and the activities of the Regulatory Affairs department ensuring that regulatory submissions with the required data are submitted correctly to the concerned authorities to previously agreed timelines. The role holder will ensure the departmental staff are motivated to contribute and achieve departmental targets and objectives, and the wider business objectives.
The Head of Regulatory Affairs also co-ordinates Clinical trials conducted on behalf of the company by third party contractors .
Essential Duties and Responsibilities:
- Assists the New Product Development & Regulatory Affairs Director in putting together the annual budget for the department
- Manage budgets for regulatory affairs and clinical trials.
- Responsible for ensuring team productivity and efficiencies within established departmental budget.
- Ensure that submissions made to Health Authorities are made in the most economic ways at the least cost
- Ensure that team members pay correct fees to health authorities for any submissions
- Ensure that any additional data requested by Health Authorities is generated at minimal cost
- Work closely with colleagues in procurement, manufacturing, quality , sales, marketing and in multidiscipline teams to ensure company objectives are met
- Monitor, analyse and report on department performance
- Ensure that submissions made to health authorities adhere to agreed submission dates as agreed with relevant departments
- Liaise with other departments within the company ensuring that data requirements for required submissions are communicated and generated to deliver the change required within the required time
- Work appropriate departments ensuring regulatory approvals are communicated and ensuring changes are implemented so as to ensure that launch / implementation dates are met.
- Work with cross functional teams allowing new products to be brought to market in the format that the market requires and as quickly as possible .
- Liaise with regulatory authorities and experts relating to regulatory submissions
- Lead the submission of all new product applications to the regulatory authorities in various European countries and other international territories, ensuring that approvals are gained in accordance with agreed timelines.
- Maintain and renew, as necessary, all product licences, including manufactured and distributed products, as well as Specials.
- Lead the preparation of clinical trial documentation and ensure that clinical trial medicines are manufactured or procured to allow the clinical trial to start when approval for the trial is granted.
- Manage Clinical trials conducted by third parties on behalf of the company including overseeing the submission of Clinical Trial Authorisations and Ethics committee applications and other permits that may be required.
- Act as the Company’s representative in directly managing the interaction with the various regulatory authorities.
- Review and upgrade, as necessary, the Regulatory Affairs Department’s systems, processes, SOPs and information systems, to ensure that the demands on the Department are met in the most efficient and cost-effective way.
- Provide strategic regulatory input and support to the new product development process within the Company.
- Establish/maintain effective working relationships with other company areas as necessary.
- Provide leadership, direction, training and development to the Regulatory Affairs team of eight regulatory specialists.
- Manage the budget for the Regulatory Affairs Department, both headcount and non-headcount-related expenses.
- Keep up to date with legislation and regulations and provide regulatory input to internal and external business partners
- Responsible for attracting, retaining and motivating team members to achieve effective performance standards
- Organise and manage the training and development of Regulatory affairs staff
- Support learning and growth through the training promise
- Responsible for the interviewing, hiring and training of employees
- Conduct the following
- Target setting and appraising performance
- rewarding and disciplining employees
- addressing complaints and resolving problems
Specific Departmental Functions
- Responsible for providing information, and data on regulatory and other activities to the Director of New Product Development and Regulatory Affairs
- Responsible for Health and Safety of self and staff
- Maintains good knowledge of relevant governance, SOP’s and ways of working
Qualifications, Skills and Experience:
To be considered for this Head of Regulatory Affairs position, you will have the following qualifications, skills and experience:
- Good commercial sense, combined with an absolute commitment to high regulatory standards.
- Strong management, communication and interpersonal skills, with the ability to take a leadership role in regulatory affairs, with a proactive, supportive approach.
- Excellent planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation.
- Good people management skills, with a real interest in developing his/her subordinates.
- Personal gravitas necessary to represent the Company effectively in dealing with regulatory authorities.
- Able to operate effectively in a rapidly growing company that in some areas still needs to establish clear processes.
- A can-do attitude with a willingness to get actively involved in all aspects of regulatory work
- Set targets, monitors and reports on efficiencies and productivity
- Provide updates on regulatory affairs department performance.
- Communicate effectively in both written and oral form
- A pharmacy, chemistry or life sciences graduate
- Membership of The Organisation of Professionals in Regulatory Affairs (or eligible to be a member)
- 10 years regulatory experience gained in an international pharmaceutical environment, ideally with some experience of biotech products.
- Experience of National, Mutual Recognition and Centralised Procedures.
- A philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic “necessary” function.
- Accustomed to interacting effectively at all levels within the organisation, as well as with regulatory authorities and external partners/distributors.
How to apply:
For more information regarding this Head of Regulatory Affairs position, please contact Moin Din at CK Clinical on +44 (0)207 470 5670 or email firstname.lastname@example.org. Please quote reference 24783 in all correspondence.