Ref. no.: LD69042
Job description: Our client is currently looking to recruit a Senior Regulatory Affairs Consultant. This role can be based in Dublin or London.
Summary:
The Senior Regulatory Affairs Consultant will work within a multidisciplinary team environment to provide regulatory expertise and leadership to other more junior team members. The individual will be responsible for managing and coordinating activities necessary to ensure client company compliance with the requirements of EU competent authorities. On behalf of client companies, obtain regulatory approvals for designated marketing authorization applications, product maintenance applications and clinical trial submissions.
Major responsibilities include;
• Development and execution of proactive and pragmatic regulatory/clinical strategies to support timely approval of regulatory applications in support of client company’s corporate objectives.
• Oversee and assist in the preparation of marketing authorization applications and clinical trial applications to support exploratory and development projects and ensuring the documentation meets relevant regulatory requirements.
• Helping, company and client companies to ensure regulatory compliance.
• Provision of sound regulatory advice to clients.
• Preparation of excellent quality regulatory documentation
• Project management of client projects and representation of company and client companies at meetings.
• Project management of any project work delegated to other consultants on the team.
• Coordinating the preparation of a core clinical trial approval package for each clinical study.
• Supporting client regulatory/clinical departments to secure clinical trial approvals on behalf of client companies.
• Marketing activities
This position requires substantial experience of gaining MAA and CT approvals in the EU and the associated experience of the EU requirements for GMP and GCP as applied to Drug Products, and Clinical Trial Supplies and manufacture.
Supervisory Responsibilities:
All subordinate consultants.
Job Requirements:
1. Bachelor’s degree in pharmacy, a life science or a biomedical discipline.
2. Over 5+ years experience of the pharmaceutical industry, with 4+ years regulatory affairs experience in a CRO, biotech or pharmaceutical company including demonstrated expertise in EU MAA and CT submissions.
3. A disciplined work approach with the ability to plan activities considering all resources necessary to achieve the project objectives.
4. The ability to establish priorities from among a number of demands and to handle interruptions effectively.
5. Hands-on approach to work.
6. Excellent communication skills required, both verbal and written.
For further information please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com .
