Pharmanovia is a fast-growing pharmaceutical company with a portfolio of over 20 brands across 140+ markets. Our team of over 200 employees are based globally across our offices in the UK, Denmark, Netherlands, Switzerland, Dubai, India, Australia, Singapore and Italy.
Since we first opened our doors in 2013, we have focused single-mindedly on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the globe. We specialise in many different areas including cardiovascular, women’s health and endocrinology, neurology & pain, gastroenterology and oncology, and many others. Further details of our products can be found on our website.
Pharmanovia are seeking a highly motivated individual who will work closely with the Head of Projects and the Projects Department Manager to: Provide advice on to the Projects department on the planning of new and ongoing divestments from a regulatory prospective Management and execution of designated regulatory projects, to be agreed timelines. Preparation and submission of the corresponding regulatory dossiers
KEY TASKS & RESPONSIBILITIES:
- Prepare and submit applications of a high standard to regulatory authorities in a timely fashion, 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
- Good knowledge of variation procedures such as types, timings, bundling etc 02/04
- Knowledge of the various regulatory procedures including Centralised procedure, Decentralised Procedure, MRP, national Procedures in UK and within Europe
- Knowledge of global regulatory requirements including emerging markets
- 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.
- Maintain up to date knowledge of regulatory requirements and advise colleagues and management of implications of new or changing requirements.
- Contribute to setting up Departmental procedures and policies.
- Ensure that documentation in relations to own projects is maintained in orderly fashion and can be readily retrieved. • Contribute to other Departmental activities, when needed.
- Management of other Projects Department regulatory affairs staff
- Strong communication skills with internal and external customers and colleagues
- Updating of internal documents such as trackers and Gantt charts
KEY ACCOUNTABILITIES AND QUALIFICATIONS:
- Degree in Pharmacy, Chemistry or Life Sciences
- Proven of experience in Regulatory Affairs in the generic or innovator pharmaceutical industry
- Experience in CIS, Middle East, EU, ASIA-Pacific markets
- Preparation of dossiers for MAH transfers, variations, renewals, MAA
- Strong Understanding and knowledge of life-cycle maintenance activities like variations, renewals, notifications
- Understanding of Medical Information and Pharmacovigilance requirements
- Strong attention to detail
- Able to work flexibly and under own initiative