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Graduate, Regulatory Affairs

1 month ago

Basildon, United Kingdom Ortolan Group Full time

Graduate, Regulatory Affairs

Based in Basildon, Essex

Salary: Competitive + Benefits + Bonus

Start date early September 2025

If you have a keen interest in regulatory operations and want to develop a deep and broad understanding of the critical role that regulatory affairs plays in supporting pharmaceutical product life cycle management, 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, Italy, Spain, and South Korea.

We are an agile and imaginative 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 Scheme:

We are passionate about providing early pathways into pharma for graduates and have won the Pharma Industry Awards UK's Graduate Training Programme of the Year in September 2023. This award celebrates those pharmaceutical organisations offering best-in-class graduate training and development programmes.

Our inclusive, high-performance culture provides opportunities to continually learn, develop and try new things. We have designed this programme to help graduates evolve and refine their skills, by working closely with our leadership team on high level projects. We are providing a pathway for bright talent in a unique, dynamic section of the pharmaceutical industry.

During this two-year programme you will have the opportunity to get real hands-on experience and contribute to large-scale real-world pharmaceutical projects. At the end of the successful completion of our scheme, you will have strong employment prospects as we hope to be able to offer you the chance to secure a full-time role with our brightest minds, in a department that will keep developing your career.

The role:

As a Graduate in Regulatory Affairs, 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. You will critically evaluate the evidence generated during the development and use of the product for its suitability to support obtaining/managing marketing authorisations and approvals for clinical studies, in line with regulatory requirements. You may get the opportunity to work on the generation of new dossiers or on procedures to support the registration of our products.

Reporting into the Senior Director Regulatory Affairs, key skills required for this role are a basic understanding of pharmaceutical legislation, great organisational skills, strong attention to detail, and a proactive and problem-solving nature. You will need to be a confident communicator and have the ability to be flexible and multi-task in a fast-paced environment. You will have an inquisitive mind and an appetite to develop your technical skills.

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.

What you'll be involved in:

  • Supporting the preparation of core dossiers and submissions for global roll out
  • Authoring and collating supporting documents for submission, including M1 and M3 dossier sections as necessary, justification documents and Product Information
  • Interpreting applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans
  • Communicating with local health authority (HA(s), local consultancies/ distributors and internal stakeholders, as needed, to ensure timely and accurate submissions
  • Supporting or facilitating communication between the HA(s) and the project team, attending and leading agency meetings, if required
  • Coordinating and soliciting components of the submission from various functional areas, distributors and CMOs
  • Proactively identifying project issues to the project team and supports mitigation plans

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.

About you:

  • On track to achieve a minimum 2.1 degree in pharmaceutical science or related discipline
  • Experience in a relevant work environment is a plus, but not essential
  • Excellent standard of written and verbal communication in business English
  • Strong aptitude for technology and highly proficient in the use of MS Office, including intermediate to advanced level Excel and PowerPoint
  • Familiarity with the US or EU regulatory framework and guidelines
  • Ability to relate to stakeholders at all levels and from different cultural backgrounds
  • First class numerical and analytical skills
  • Proactive approach to problem solving and critical thinking
  • Strategic thinking and data analysis skills
  • Detail-oriented and organised, with the ability to manage multiple tasks and deadlines simultaneously
  • Ability to maintain resilience, learn quickly and navigate ambiguity
  • Collaborative, team-player attitude and a willingness to take on new challenges
  • Eagerness to learn and develop new skills

What we offer:

We offer a competitive salary and rewards package including holiday, health & well-being 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.

Interviews will be held from December 2024 until March 2025. Offers should be made in March/April, with the role starting at the beginning of September 2025.

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.