Description
Senior Regulatory Associate - £45,000 to £48,000 excellent benefits - Global Pharma - Midlands - Regulatory Affairs Opportunity.An opportunity has arisen to join the regulatory affairs team with a top Global Pharmaceutical company.
This global Pharma is looking for an experienced Senior Regulatory Associate to join their Regulatory team. This position offers fast career progression, and immediate mentoring responsibilities which could lead into a management role. You will be reporting into the Regulatory Director on a daily basis and will be expected to liaise with other teams regularly. For a committed and driven individual this is an excellent opportunity working for a globally respected company.
Key responsibilities:
- 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.
- Maintain and expand UK & ROI Marketing Authorisation portfolio.
- 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.
- 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.
Key Skills:
- A detailed knowledge of regulatory and legislative requirements for medicines in the target markets.
- Excellent communication skills - both written and verbal with the ability to deliver complex messages to senior managers, peers and to non-technical functions, in a straightforward and logical manner.
- A minimum of 5 years of experience in medicines regulatory affairs, but with commercial exposure and understanding of product development and life cycle.
- Excellent presence with development and brand partners and an ability to influence partners to adopt successful regulatory strategies.
- Familiarity and competence with the eCTD format and publishing solutions.
Real Pharma are a world leader in placing regulatory affairs professional, with nearly 10 years experience in this market we are specialists who make sure we place the correct candidate in the correct environment
For more information on this opportunity please contact our Regulatory consultant Ben Moseley on or send you CV to b.moseley(a)realstaffing.com
To find out more about Real please visit www.realstaffing.com