Regulatory Compliance Executive

1 month ago

United Kingdom Pharmanovia Full time

Basildon, Essex (hybrid: 3 days office, 2 days home)
Salary: Competitive + Benefits + Bonus
If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceuticals sphere then we want to hear from you
Join us to help improve peoples’ lives and make healthcare better for everyone
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.
We value our heritage and foster an entrepreneurial spirit.
We reinvest in our future – in our products, our brands, and our people.
We give back to our communities.
Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.
Reporting to Director, Regulatory Affairs, you will be a key member of the team which is responsible for submission of regulatory safety updates including SmPC, PIL reviews as well as PSUR/PBERs and RMPs.
Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. Work within a framework of internal procedures and working practices to ensure compliance with regulatory requirements
Interface with key safety and governance stakeholders across Pharmanovia and partners
Management of Global Labelling Information in appropriate systems and eDMS
Keep project team abreast of regulatory decisions, evolving regulatory requirements, risks, and mitigation plans
Communicate with local health authority (HA), local consultancies/ distributors and internal stakeholders, as needed, to ensure timely and accurate submissions
Maintain controlled records for historical, current, and ending labelling changes, and communicate labelling changes to stakeholders at the time of implementation
Work closely with other Regulatory Affairs colleagues, Artwork and Supply chain colleagues
Responsible for proofreading, peer-review of submission packages, review and approve of product information, including artworks
Work with colleagues in markets worldwide to ensure implementation of the company core datasheet into local prescribing/patient information
Candidates with proven relevant experience gained within a pharmaceutical company, CRO, or similar organisation, are likely to have the skills required to be successful in this role. Bachelor’s degree in science/health discipline
Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
Awareness of regulatory submission structure and content (e.g., Experience in compliance and maintaining product life cycle databases and RIMs systems
Ability to effectively communicate with regulatory authorities
Awareness of EU regulatory framework and guidelines
Strong attention to detail and accuracy, including composing and proofreading materials
Ability to write scientific and technical documents is desirable
Excellent time management skills with demonstrated ability to juggle multiple competing tasks and demands
Second language, especially German, Italian, or French, is desirable
We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.
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