Senior Regulatory Affairs Specialist

1 month ago

Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time
Job Title: Senior Regulatory Affairs Officer

We are seeking a highly skilled Senior Regulatory Affairs Officer to join our team in the EU. As a key member of our Regulatory Affairs department, you will be responsible for managing the assigned Ethypharm UK portfolio, ensuring adherence to relevant regulations and standards.

Key Responsibilities:
  • Portfolio Management: Specialize in managing regulatory affairs for UK & EU products within Ethypharm portfolio, ensuring compliance with regulatory requirements.
  • 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.
  • Maintain Regulatory Database: Ensure that the regulatory drive, SharePoint, trackers, and relevant databases are consistently updated and maintained with submission documents throughout the regulatory procedure.
  • Safety Variations: Ensure safety variations, such as updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio.
  • 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:

We are looking for a highly skilled and experienced Regulatory Affairs professional with a minimum of 7 years of experience in the pharmaceutical industry. You should have a life science degree and experience of working in a matrix organisation and collaborating at all levels, including external authorities and partners.

You should have excellent planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation while maintaining attention to detail. You should also be able to communicate effectively in both written and oral form and 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.

About Ethypharm Group:

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.

We have 1,700 employees dedicated to our various pharmaceutical activities, of which 1,400 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.

We work closely with the authorities and healthcare professionals to ensure that our medicines are used appropriately and that patients have access to them.

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