Pharmaceutical Regulatory Affairs Specialist

3 weeks ago

Wooburn Green Buckinghamshire, United Kingdom Ethypharm Full time

We are recruiting for a Regulatory Affairs Officer - EU on a fixed term contract ending in September 2025. The role reports to our Regulatory Affairs Manager – EU and is based in our offices near High Wycombe.
The primary objective is to ensure regulatory responsibilities for dedicated products are met. This is achieved through effective collaboration with the EU-based MA Holder (Ethypharm SAS France) and other entities within the Ethypharm group.

Specialise in managing regulatory affairs for UK & 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.

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

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

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.

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.

Regulatory experience in the pharmaceutical industry minimum 7 years
A philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic “necessary” function.
Good commercial sense, combined with an absolute commitment to high regulatory standards.
Excellent planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail.
Must 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.

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.

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

  • EU Pharmaceutical Regulatory Manager

    4 weeks ago

    Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

    About the JobWe are currently looking for a highly skilled Regulatory Affairs Officer to join our team in the UK. This is an exciting opportunity for someone who is passionate about regulatory affairs and has a strong background in the pharmaceutical industry.Job SummaryThis role involves managing regulatory affairs for UK & EU products within our portfolio,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in High Wycombe. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with EU regulations and standards.This is a fantastic opportunity for an experienced professional to take on new challenges and contribute to the...

  • Regulatory Affairs Officer

    3 weeks ago

    Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

    We are recruiting for a Regulatory Affairs Officer - EU on a fixed term contract ending in September 2025. The role reports to our Regulatory Affairs Manager – EU and is based in our offices near High Wycombe. The role is responsible for managing the assigned Ethypharm UK portfolio, including UK and EU MAs. The primary objective is to ensure regulatory...

  • Regulatory Affairs Professional

    2 weeks ago

    Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

    **Regulatory Affairs Professional Wanted:**Ethypharm is seeking a Regulatory Affairs Professional to support the pharmacovigilance department in ensuring compliance with GVP Modules and local UK regulations. This exciting opportunity offers the chance to work in a dynamic environment, collaborating with international teams and authorities.**Key...

  • Regulatory Affairs Officer

    2 weeks ago

    Wooburn Green, United Kingdom Ethypharm Full time

    We are recruiting for a Regulatory Affairs Officer - EU on a fixed term contract ending in September 2025.The role reports to our Regulatory Affairs Manager – EU and is based in our offices near High Wycombe. The role is responsible for managing the assigned Ethypharm UK portfolio, including UK and EU MAs.The primary objective is to ensure regulatory...

  • Regulatory Affairs Officer

    5 days ago

    Wooburn Green, United Kingdom Ethypharm Full time

    We are recruiting for a Regulatory Affairs Officer - EU on a fixed term contract ending in September 2025. The role reports to our Regulatory Affairs Manager – EU and is based in our offices near High Wycombe.The role is responsible for managing the assigned Ethypharm UK portfolio, including UK and EU MAs. The primary objective is to ensure regulatory...

  • Regulatory Affairs Officer

    5 days ago

    Wooburn Green, United Kingdom Ethypharm Full time

    We are recruiting for a Regulatory Affairs Officer - EU on a fixed term contract ending in September 2025. The role reports to our Regulatory Affairs Manager – EU and is based in our offices near High Wycombe.The role is responsible for managing the assigned Ethypharm UK portfolio, including UK and EU MAs. The primary objective is to ensure regulatory...

  • Regulatory Affairs Officer

    6 days ago

    Wooburn Green, United Kingdom Ethypharm Full time

    We are recruiting for a Regulatory Affairs Officer - EU on a fixed term contract ending in September 2025. The role reports to our Regulatory Affairs Manager – EU and is based in our offices near High Wycombe.The role is responsible for managing the assigned Ethypharm UK portfolio, including UK and EU MAs. The primary objective is to ensure regulatory...

  • Regulatory Affairs Officer

    2 days ago

    Wooburn Green, United Kingdom Ethypharm Full time

    Job Description We are recruiting for a Regulatory Affairs Officer - EU on a fixed term contract ending in September 2025. The role reports to our Regulatory Affairs Manager – EU and is based in our offices near High Wycombe. The role is responsible for managing the assigned Ethypharm UK portfolio, including UK and EU MAs. The primary objective is to...

  • Regulatory Affairs Specialist Lead

    2 weeks ago

    Hatching Green, United Kingdom Gowan Company Full time

    We are seeking a highly experienced Regulatory Affairs Specialist Lead to join our team as a Global Product Strategist. In this role, you will lead, listen, inspire, and connect the related product science team with key stakeholders working within their fields on Gowan projects while maintaining a keen understanding of commercial objectives.

  • Head of Medical Affairs

    9 hours ago

    Buckinghamshire, Buckinghamshire, South East England, United Kingdom CK Group Full time

    Medical Affairs Manager / Head of Medical Affairs The CK Group are proud to be working exclusively with a family-owned pharmaceutical company to recruit a Head of Medical Affairs. This is an exceptional opportunity for an experienced medical affairs professional (GMC registered medical doctor or GPhC registered pharmacist), to lead the medical and regulatory...

  • Head of Medical Affairs

    5 hours ago

    Buckinghamshire, United Kingdom CK Group Full time

    Medical Affairs Manager / Head of Medical Affairs The CK Group are proud to be working exclusively with a family-owned pharmaceutical company to recruit a Head of Medical Affairs. This is an exceptional opportunity for an experienced medical affairs professional (GMC registered medical doctor or GPhC registered pharmacist), to lead the medical and regulatory...

  • UK MA Compliance Expert

    3 weeks ago

    Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

    About the PositionWe are seeking a highly skilled Regulatory Affairs Officer to join our team in the UK. This is an exciting opportunity for someone who is passionate about regulatory affairs and has a strong background in the pharmaceutical industry.Job DescriptionThe successful candidate will be responsible for managing regulatory affairs for UK & EU...

  • Regulatory Affairs Specialist

    4 weeks ago

    Turgis Green, United Kingdom QED Legal Full time

    Job Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at QED Legal. This is an exciting opportunity for a talented individual to work on a diverse caseload of contentious and non-contentious matters, with opportunities to progress and grow within the company.The ideal candidate will have experience in advising and...

  • EU Regulatory Professional

    3 weeks ago

    Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

    About the RoleThe successful candidate will be responsible for managing the assigned Ethypharm UK portfolio, including UK and EU Marketing Authorisations. You will work closely with our Regulatory Affairs Manager – EU and other stakeholders to ensure that all regulatory responsibilities are met.You will specialise in managing regulatory affairs for UK & EU...

  • Regulatory Affairs Team Manager

    4 weeks ago

    Hatching Green, United Kingdom Gowan Company Full time

    About the Role:We are looking for a skilled Regulatory Affairs Team Manager to join our team at Gowan Company. In this role, you will be responsible for leading a team of product scientists and ensuring the quality of regulatory submissions.You will work closely with the regional registration teams and global science discipline teams to communicate and align...

  • Contracts and Tenders Specialist

    1 week ago

    Wooburn Green, United Kingdom Linklife Ltd Full time

    **Contracts and Tenders Specialist** Linklife Recruitment is currently recruiting for a Contracts and Tenders specialist for our client based in High Wycombe HP10. **Hours**: 9am-5pm **Salary**: £35,000-£40,000 **Duties**: - Develop relationships between the company and key external contracts customers across both sectors - Plan for framework review...

  • Regulatory Affairs Scientist

    6 days ago

    Forty Green, United Kingdom Lonza Full time

    Overview: Lonza is a leading global life sciences company operating across five continents. As a key player in the industry, we value talented individuals who work together to devise innovative ideas that help businesses improve people's lives. We foster an environment where our employees can own their careers and genuinely make a difference.Job Title: Lead...

  • Scientific Compliance Expert

    3 weeks ago

    Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

    About Ethypharm:We are 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.The Opportunity:We are seeking...

  • Regulatory Affairs Specialist

    1 week ago

    Buckinghamshire, United Kingdom The Collective Network Limited Full time

    Salary and BenefitsWe offer a competitive salary of £85,000 - £110,000 per annum, depending on experience, plus benefits including flexible working hours and hybrid working options. Our company values work-life balance and provides opportunities for career growth and development.