Description
Senior Regulatory Affairs Officer -Midlands- £45,000The regulatory team is now looking to expand and add a Senior Regulatory Affairs Officer. This person will play an active part in defining the future evolution of the team and help develop technical capabilities as well as helping define the department's direction and team charter.
This opportunity will involve the following responsibilities:
- Maintain and expand UK & ROI Marketing Authorisation portfolio.
- Accountable for maintaining existing Marketing authorisations for products in designated categories in order that The Company can continue to sell these medicines. Accountable for regulatory support in OLD agreements with third parties.
- Responsible for relationship-building and negotiation with and influencing of regulatory authorities such as MHRA, IMB, EFSA, FSA and HSE as necessary to obtain Marketing Authorisations and approvals, on time and on terms acceptable to The Company and in line with Brand Strategy.
- Represent the regulatory function in cross-functional project teams. Proposing regulatory strategies, influencing and negotiating with colleagues to advise on, procure, co-ordinate and evaluate scientific data. Presentation of this data, in the correct format to the licensing authority. Responsible for proposal of and adherence to regulatory timings.
- Responsible for minimising regulatory risk to products and products and product approvals by ensuring adequate compliance of licences/registrations at all times.
- Contribute to the growth objectives of The Company whilst ensuring that licensing activities are executed in the most cost efficient way (cost/time/resource).
The right candidate will have a detailed knowledge of regulatory and legislative requirements for medicines in the target markets. Must have experience in medicines regulatory affairs, with commercial exposure and understanding of product development and life cycle. Additionally, the candidate should have excellent communication skills (written and verbal), ability to influence key stakeholders, familiarity with eCTD and a good all round regulatory knowledge.
For more details on the opportunity, please contact one of our regulatory team, Karan Baxi, on or email ka.baxi(a)realstaffing.com
Real Staffing are a global leader in regulated sciences, pharmaceutical, biotechnology and medical devices recruitment. Our Regulated Sciences Division is one of the largest teams globally, specialising in Quality Assurance and Regulatory Affairs since 2005 and is a stand alone multi million pound business. We have a dedicated team that deal with both permanent and contract positions, from associate to Director roles within Regulatory Affairs. If you would like to discuss this further, please get in touch with the team on .
To find out more about Real please visit www.realstaffing.com