Regulatory Affairs Consultant
Are you looking for a new role as a Regulatory Affairs Consultant? An outstanding opportunity has arisen for Regulatory Affairs Consultant of the highest calibre to join one of the world's largest pharmaceutical companies.
Are you interested in advising the project team and/or regional therapeutic area leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates within Oncology European Regulatory Affairs? If the answer is yes, this role is for you!
This is an initial 12 month contract position with a global pharmaceutical client based in the Buckinghamshire area, full time 37 hours per week.
- Free on site gym
- Free parking
- Weekly pay
- Holiday pay
- Pension plan
- On site discounted branded coffee shops and restaurants
- Drive understanding of central and national regulatory requirements
- 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
- Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
- 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. Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
- Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
- Negotiate labelling with Regulatory Agencies, going through each of the back-up strategies if necessary
- Input in document and process development
- Clinical Trial Applications (CTA)
- Marketing Authorization Application (MAA)
- Resource Planning and Management
- Provide line management, coaching and guidance to Regulatory Professionals as appropriate
Essential Knowledge & Skills
- Negotiating and conflict handling skills
- People management skills
- Complex project management skills
- Oral & written communication skills
- Organization & multi-tasking skills
- Knowledge of the applicable therapeutic area / Oncology European Regulatory Affairs
- In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions
Qualifications and experience:
- University degree - medical or paramedical (pharmacy, biology, veterinary) 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
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.