Our client is part of an integrated agency that provides high-level technical competence and specialist expertise within medical communications, medical affairs, and market access. Due to continued growth, they are now looking for a Principal Regulatory Writer to join their established regulatory branch. This role can be fully remote, but you must be based in the UK and will have access to their offices in Cheshire and London if you prefer. Some locations within Europe may be considered.
In this role, you will provide technical and scientific leadership of internal teams and be responsible for designated client accounts with budgets and deliverables up to £1–2 million. You will line manage, lead, and mentor a team working with a variety of clients throughout Europe and the US. Involved with the full range of regulatory offerings, some deliverables you will work on will include protocols, narratives, CSRs, briefing packages, regulatory responses, and CTD submission modules. It is essential that you have experience leading dossier submissions.
This is a great chance to join a successful agency in a role that offers learning and career advancement across a range of therapeutic areas!
The successful candidate will receive a competitive salary with an excellent benefits package that includes 25 days holiday, pension, bonus, healthcare, health cash plan, well-being allowance, retail discounts and rewards like cinema tickets, and more.
Responsibilities:
- Leadership of designated accounts through line management and mentoring of teams and taking responsibility of the full range of regulatory deliverables
- Provide guidance on regulatory processes, document quality, regulatory strategy, client procedures
- Develop or review budgets, track and manage project finances/reconciliations
- Contribute to new business development and identify and pursue organic growth on existing accounts
Knowledge, Skills and Abilities:
- Degree or post graduate qualification in a life science
- Significant previous experience regulatory writing experience
- Previous experience leading dossier submissions essential
- Excellent communication and interpersonal skills
- Organisational and time management skills
- Previous mentoring or line management experience
To be considered for this role you must live in the UK and have significant previous regulatory writing experience. Some locations within Europe may also be considered, but will be taken on a case-by-case basis.For more information or to submit an application for this role, please contact Sabine Willms on 01932 797963 or sabine.willms@medcommspeople.com.
MedComms People is a specialist recruiter in medical and healthcare communications. We’ve built many long-term relationships with candidates and clients. We’re now trusted recruitment partners to many leading companies, big, small, network and independent.
Our consultants are knowledgeable and professional and will be happy to offer information and advice. We are with you every step of the way, providing a supportive and communicative service that we will tailor to your unique needs.
Due to client sensitivities and in some cases timing issues we are unable to advertise all the roles that we are currently working on. If you can’t find the perfect role amongst our advertised roles, please call Sabine Willms on 01932 797963 to discuss your requirements in more detail.
£58000 - £70000 per annum, Benefits: 25 days holiday, pension, bonus, healthcare, health cash plan, well-being allowance, retail discounts and rewards like cinema ti
