Senior Regulatory Manager - Pharma
Atnahs have an opportunity for a highly motivated and dynamic regulatory professional within the projects team. Working closely with the Head of Projects and the Projects Department you will be advising on new and ongoing divestments from a regulatory prospective. Our projects department, led by the Head of Projects, is comprised of Project Managers, Regulatory Affairs Managers and Artwork Coordinators and are responsible for all activities required to transfer products from divesting partners.
Atnahs is a fast-growing pharmaceutical company. Our team of over 90 employees are based across our offices in Basildon (UK), Copenhagen (Denmark) and Vadodara (India).
We acquire, develop and market a portfolio of mature branded medicines globally:
Acquire - We acquire "mature" (i.e. post-patent expiry), established branded prescription medicines from large cap and specialty pharma.
Develop - We develop line extensions (new formulations or new markets) to the medicines we acquire. We also develop our own niche generic medicines in-house.
Market - We currently own and market a portfolio of more than 18 medicines and operate in more than 130 markets globally.
Prepare and submit applications of a high standard to regulatory authorities, working in collaboration with consultants, local partners and distributors where necessary. These include new licence applications, renewals, variations, artwork changes, updates and any other relevant applications or notifications.
Manage international regulatory consultants.
Evaluation of dossiers received from third parties.
Recommendation of appropriate actions needed to ensure expeditious submission and approval.
Compilation and submission of marketing authorisations and variation applications.
Preparation of responses to regulatory questions in conjunction with third parties.
Commission and review artwork for packaging components, in accordance with departmental and company procedures.
Provide advice to colleagues and management on process, status, problems etc.
Project co-ordination, project tracking and updating Gantt charts.What we are looking for:
A Degree in Pharmaceutical Science or other relevant discipline.
Relevant regulatory experience gained in a medical device, FMCG or pharmaceutical company.
Experience should include responsibility for the UK, Europe and emerging markets.
Knowledge of all applicable regulations, GMPs, classification, pre-market submission and registration requirements, labelling and advertising procedures.
Knowledge of variation procedures such as types, timings, bundling etc .
Knowledge of the various regulatory procedures including centralised and decentralised Procedure, MRP, national procedures in UK and within Europe.
Knowledge of global regulatory requirements including emerging markets.
Strong communication skills.
Level - mid management
Applicants must have the right to work in the UK.
Full time, permanent position
By applying for this role, your details will be sent to Ortolan People, who are acting as consultants for the hiring company. Ortolan People are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible
Packaging And Labeling