Aug
18
Regulatory Affairs Executive
August 18, 2023 | Comments Off on Regulatory Affairs Executive
Regulatory Affairs Executive
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!
Why Pharmanovia?
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.
Our core behaviours are:
- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- 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.E., India, Singapore, Spain, Italy, and South Korea.
We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.
Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.
About the role:
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. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.
Main responsibilities & duties:
- 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
- Review of prescribing and patient information for EU, US, Canada, Australia and emerging markets
- Contribute to the review documentation to support Labelling Committee
- Expertise in artwork requirements and review in line with regulations
- Prepare documentation to support global and country/regional Product Information (PI) maintenance, including author and manage PI annexes and associated submissions
- 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
- Support the development of CCDS, package inserts and equivalents and their associated Patient Labelling Documents
- Work with colleagues in markets worldwide to ensure implementation of the company core datasheet into local prescribing/patient information
About you:
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. We are also looking for:
- 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., MAA, NDA)
- Experience in compliance and maintaining product life cycle databases and RIMs systems
- Ability to effectively communicate with regulatory authorities
- Experience in CCDS and SmPC updates, labelling process and artwork approval, and experience of global labelling regulations
- 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
- Strong organisational skills to establish priorities including scheduling and meeting deadlines
- Ability to work successfully within cross-functional teams as well as independently
- Excellent professional communication skills, both written and verbal
- Second language, especially German, Italian, or French, is desirable
What we offer:
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.
By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.