We are currently searching for 3 UK Affiliate Regulatory Managers to join our client on an initial 6 month contract basis, with potential to extend. You will ideally have both post approval and hands on publishing experience, working with the MHRA.
- Work closely with global and local colleagues to agree on regulatory data requirements.
- Critically evaluate submission packages in line with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA Applications within agreed timeframes
- Monitor and influence assessment process to expedite and optimise the outcome of their submissions.
- Drive negotiations with the MHRA to ensure best possible outcome which may include for example, optimal product labelling or assurance of supply continuity and delivery of their commitments and deadlines.
- Ensure Communication of any regulatory changes to the business as necessary to support licence compliance
- Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs and their Educational Material.
- Assist Senior RA team members with new MA submissions e.g. Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness
- Provide regulatory advice to global and UK business on all aspects of maintenance work including advice on data requirements, medicines legislation/guidelines, to ensure informed decision making and best chance of optimal assessment timing and outcome.
- Provides support for divestment and in-licensing opportunities.
- Proactively builds relationships externally (MHRA) and internally (BF, Med Info, TechOps, Patient Safety, Global colleagues), so that business needs are met.
- Contribute to the continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.
- Self-initiates personal development opportunities
- Relies on instructions and pre-established guidelines to perform the functions of the job.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to firstname.lastname@example.org
- Agency: Achieva Group Limited
- Contact: Tim Barratt
- Phone: 01727811634
- Reference: BH-25892
Website: Achieva Group Limited
- Posted: 14th July 2021
- Expires: 11th August 2021