Senior Regulatory Affairs Officer

Description

Senior Regulatory Affairs Officer -Central England- £45,000

The 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 maintaining and expanding the UK&I Marketing Authorisation portfolio. They will be responsible for minimising regulatory risk to products and product approvals by ensuring adequate compliance of licenses/registrations. Whilst ensuring that licensing activities are executed in the most efficient way, they will contribute to the growth objectives of The Company.

This role will represent the regulatory function in cross-functional project teams, proposing strategies, influencing and negotiating with colleagues, evaluate and present scientific data. They will be accountable for maintaining existing Marketing Authorisation for products and regulatory support in old agreements.

Finally they will be responsible for relationship building, negotiating with influencing regulatory authorities such as MRHA, IMB & HSE as necessary to obtain Marketing Authorisations and approvals on time and on acceptable terms.

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