ProClinical is seeking a Regulatory Affairs Associate for a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. This is a 6-month contract opportunity has to join the International Regulatory Affairs team based in Cambridge.
- This position will be in the European HIV group in International Regulatory Affairs and will be responsible for the preparation of regulatory submissions.
- Prepares non-clinical, clinical and safety regulatory documentation, as required, in accordance with regulations, post licensing commitments and legal obligations of the marketing authorisation holder via the European Centralised procedure, e.g. variations, renewals, responses to questions, Follow-up Measures, PSURs etc
- Prepares regulatory documentation to support Clinical Trial activities
- Responsible for ensuring product packaging and associated information is updated and maintained in accordance with Marketing Authorisations including the review and management of labelling translations and artwork
- Participates in HIV Regulatory team meetings, product team meetings and study management team meetings (for CTAs)
- Responsible for gaining and/or maintaining a broad knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
Skills and Requirements:
- Degree in biological/life sciences or pharmacy
- Relevant experience in Regulatory Affairs
- Experience representing Regulatory Affairs on cross-functional teams
- Experience of working with the European Medicines Agency is preferred.
- Experience of working with clinical trials in Europe is preferred
- Excellent oral and written English communication, organizational and teamwork skills
- Demonstrate judgment and problem-solving skills, analytical and assessment skills and planning and information seeking skills
- High attention to detail is also required and able to understand and effectively relate to external and internal customers
- Resilient profile with the ability to deliver in an ambiguous environment
- Ability to engage and manage multiple stakeholders to achieve the objective
- Curious with learning agility
- Operationally excellent
- Organised with systematic approach to prioritisation
- Process orientated to achieve the business objective
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.