Regulatory Affairs Manager - Wooburn Green, Buckinghamshire, United Kingdom - Ethypharm

Description

Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the environment.

Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations

Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms.

With a global presence in 68 countries, the company markets its products directly in Europe and China, and has strategic partnerships in the EMEA, NA, LATAM and APAC markets. Ethypharm works closely with the authorities and healthcare professionals to ensure that its medicines are used appropriately and that patients have access to them.

To find out more about Ethypharm, visit and follow us on LinkedIn.

We are recruiting for a Regulatory Affairs Manager - EU. The role reports to Director of Regulatory Affairs and is based in our offices near High Wycombe managing a small team. This role is responsible for regulatory efforts for EU and UK products, particularly post-Brexit, where the Marketing Authorisation Holder (MAH) is Ethypharm SAS, France, while regulatory responsibilities remain under this role. The primary objective is to effectively fulfil MAH responsibilities for ESAS and other Ethypharm group entities concerning the UK portfolio.

Key responsibilities

Portfolio Management : Specialise in managing regulatory affairs for EU products within Ethypharm portfolio, ensuring adherence to relevant regulations and standards.

Gap Analysis : Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies.

New MA Applications : Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures.

Geographical Expansion : Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards.

RA Support for New Product Development : Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset.

In-licensing Support : Offer regulatory support for in-licensing activities, ensuring smooth integration of acquired products into our portfolio.

MA Compliance Maintenance : Ensure ongoing compliance and maintenance of Marketing Authorisations for the assigned portfolio of In-house manufacturing and Contract Manufacturing Organisations and oversee compliance for the team.

Safety Variations: Ensure safety variations e.g. updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio and oversee the Team submitting their assigned safety variations.

Change Control Management : Manage regulatory change controls, Corrective and Preventive Actions (CAPAs), and deviations, with familiarity with the SAP system preferred.

Implementation of Patient Information Leaflets (PILs) and Mock-ups: Oversee the comprehensive execution of PILs and mock-ups implementation, including finalising all procedural aspects, managing relevant national phases in each member state, collaborating with the artwork team and local affiliates/partners to create PIL mock-ups and artwork, and coordinating all necessary processes to ensure the timely implementation of new PIL mock-ups and artwork.

About you

Experience/Education

• experience in the pharmaceutical industry minimum 8 years
• science degree
• leadership and developing teams minimum 4 years.
• of working in a global matrix organisation and collaborating at all levels including external authorities and partners.

Skills/Knowledge

• Mutual Recognition and Decentralised Procedures.
• philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic "necessary" function.
• commercial sense, combined with an absolute commitment to high regulatory standards.
• planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail.
• effectively in both written and oral form
• be flexible and strive for continuous improvement

We recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business.