Just over 1000 Marketing Authorisations – that is the size of the portfolio managed by our UK Regulatory Affairs team. Join us at an exciting time as Brexit brings us more opportunities to use more novel regulatory pathways in the future for our diverse pipeline.
As the Regulatory Affairs Manager, you will provide effective regulatory support to the UK and global organisations for maintenance of assigned Marketing Authorisations whilst developing knowledge of all aspects of life-cycle management.
Your responsibilities include, but are not limited to:
Responsibilities for a number of Marketing Authorisations for which the following activities will be required:
Works closely with global and local colleagues to agree on regulatory data requirements and critically evaluates submission packages in line with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA applications within agreed timeframes
Monitors and influences assessment process to expedite and optimise the outcome of their submissions. Drive negotiations with 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 license compliance; Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs and their Educational Material
Assists senior RA team members with new MA submissions eg Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness
Provides 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.
Contributes 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. Works under immediate supervision
What you’ll bring to the role:
Life Science Degree or other relevant education.
at least 2-3 years of broad relevant regulatory work in the pharmaceutical industry.
Fluent English (oral and written).
Regulatory experience with MHRA submissions.
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!