Are you looking for a new role as a Regulatory Affairs Consultant? An outstanding opportunity has arisen for a Regulatory Affairs Consultant of the highest calibre to join one of the world's largest pharmaceutical companies.
The successful candidate will advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates.
The ideal candidate will have experience in the oncology / haematological oncology therapy areas.
This is an initial 12 month contract opportunity.
- Free parking
- Weekly pay
- Holiday pay
- Pension plan
- On site discounted restaurants
- Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
- Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
- Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labelling
- Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan
- Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labelling, study design, submissions content, and post-approval commitments
- Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
- Determine timing and strategy for Regulatory Agency meetings and scientific advice
- Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies.
- Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
- Advise team on required documents and processes to support Regulatory Agency contacts and s submission
- Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
- Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
- Ensure timely MAA availability, track critical path activities
- Responsible for submission and acceptance of MAA
- Ensure country-specific submission packages are made available to the LOCs
- Determine resource requirements for assigned projects and anticipate needs for major filings
- Provide line management, coaching and guidance to Regulatory Professionals as appropriate
Qualifications and experience:
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
- Experience with EU regulatory procedures (CP, MRP, national)
- Experience in working in project teams and/or a matrix organization
- Negotiating and conflict handling skills
- People management skills
- Complex project management skills
- Oral & written communication skills
- Organization & multi-tasking skills
- Excellent knowledge of English
- Knowledge of the applicable therapeutic area
- In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions
If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.