Regulatory Operations Officer – EU – Maternity Cover
Location: Romford
Contract Type: Full-time, 12M FTC
Working Hours: Monday – Friday, 8:30am – 5:00pm
Right to work: Please note that Ethypharm is unable to provide sponsorship for this role. Applicants must already have the right to work in the UK.
What you will do
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.
Your key responsibilities include
- 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: Support the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures.
- Geographical Expansion: Assist with the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards.
- 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
You’ll have a good understanding of National, Mutual Recognition and Decentralised Procedures and how Regulatory Affairs supports the wider business. You’ll be organised, commercially aware and able to make sound decisions, with strong communication skills, an eye for detail and a practical approach to solving problems and improving ways of working, while maintaining high regulatory standards.
Basic skills and qualifications
- Regulatory experience in the pharmaceutical industry minimum 5 years which includes the Preparation of modules for the regulatory dossier in eCTD format, submission of variations, renewals using national country specific procedures.
- Life science degree
- Good Knowledge of Regulatory UK and European procedures and regulatory filings.
- Experience of working in a global matrix organisation and collaborating at all levels including external authorities and partners.
What we offer you
- Competitive Salary
- Holiday – 25 days rising to 30 with length of service plus bank holidays
- Holiday Buy/Sell – an opportunity to buy or sell up to an additional 5 days’ holiday
- 3% Bonus – In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)
- Bravo Benefits Platform – offering a variety of discounts across well-being and lifestyle
- Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)
- Private Healthcare for yourself and your family (if applicable) with an additional Medicash health cash plan
- Pension Scheme
About us
Ethypharm is a leading mid-sized international pharmaceutical company, with strong European roots, that manufactures and provides essential medicines, 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. Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms.
At Ethypharm, you will be a part of a team dedicated and committed to improving patients’ lives.
Our Romford facility located 20 miles from the centre of London, consists of over 6700 square metres of a high-quality, modern pharmaceutical facility where we mix, fill, sterilise, inspect, pack, and label a wide range of medicines.
Why Ethypharm
We provide a workplace which is one of collaboration, teamwork and innovation. We are all different and we embrace this uniqueness in each and every one of our employees. Our commitment to you is that we want to help you unleash your full potential by supporting your training and development. We want you to be the best that you can be.
At Ethypharm 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.
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