Graduate Program – Regulatory Affairs

Based in Basildon, Essex or London

Salary: Competitive + Benefits + Bonus

Starting early September 2023

If you are a committed and agile Graduate with an interest in the regulatory world of pharmaceuticals, then we want to hear from you! 

Join us to help improve peoples’ lives and make healthcare better for everyone!

About Pharmanovia:

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.

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, 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.

Our Graduate Program – Regulatory Affairs

The 2-year Graduate scheme will offer significant development opportunities as you gain a wide understanding of regulatory affairs in key highly regulated regions such as EU, US, China, and ROW.  A Regulatory Affairs professional ensures all medicines are appropriately licensed before being sold or supplied. In this role, you will form part of a team responsible for developing and implementing strategies that support the life cycle management of Pharmanovia’s developments around the world. The role critically evaluates the evidence generated during the development and use of the product for its suitability to support obtaining and managing marketing authorisations, and approvals for clinical studies in line with regulatory requirements. You will work on the generation of new dossiers and support the registration of our products. 

The 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 duties and responsibilities:

• Supports the preparation of core dossiers and submissions for global Marketing Authorization Applications.
• Authors and collates supporting documents for submission, justification documents and Product Information.
• Interprets applicable regulations and guidelines for project team use. 
• Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks, and mitigation plans.
• Communicated with local health authority (HA(s), local consultancies/ distributors and internal stakeholders, as needed, to ensure timely and accurate submissions.
• May support or facilitate communication between the HA(s) and the project team.  Attends and generally leads agency meetings, if required.
• Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
• Proactively identifies project issues to the project team and supports mitigation plans.

About you:

• Minimum 2.1 degree in a relevant subject (e.g., Life & Health sciences, Data sciences, Quantitative disciplines, Chemistry, Economics, Business Studies, Computing, statistics)
• Strong aptitude for technology and highly proficient in the use of MS Office particularly intermediate to advanced Excel and PowerPoint
• First class numerical and analytical skills
• Excellent standard of written and verbal communication in business English
• Ability to relate to stakeholders at all levels and from different cultural backgrounds
• Flexibility to align to the working requirements of a fast-paced Graduate scheme
• Relevant work experience by the way of placement would be desirable, but not essential
• Demonstrable evidence of problem-solving
• Project management skills
• Organisational skills

What we offer:

We offer a competitive salary and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

Graduates are an important part of the team. We’re committed to having a workforce that represents every part of society. So, we’re keen to hear from candidates from all backgrounds and circumstances. We will ensure that you have the support and guidance that comes from a collaborative environment, where fresh perspectives are encouraged, and questions are welcomed.

To apply please submit your CV. Shortlisted applicants will be invited to interview in April/May. The program starts in September 2023.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing and supporting applicants. We will endeavour to respond to all applicants within three working days.