Regulatory Affairs Manager
- Experience Level
An international pharmaceutical company is seeking to recruit a Regulatory Affairs Manager to their office in Geneva. This organisation develops and commercialises innovative medicines around the world. This is an exciting opportunity to work with a company that has offices in over 50 countries worldwide.
- Integration, creation and execution of multiple global regulatory submissions and interactions with Health Authorities to support product registration and post marketing commitments
- Define Worldwide Regulatory Requirements for changes including: non-clinical, clinical & CMC strategies, prepare and issue variations and supplements, answer to authorities requests and/or incomplete letters
- Prepare and review submissions modules supporting MAAs, renewals, variations, supplements, and responses to authorities' questions
- Facilitate alignment with Quality, Regulatory, Medical Affairs, Supply Chain and CMC staff to support communication and information sharing, with the goal of delivery of a high-quality regulatory submission package
- Quality check submissions for compliance with applicable regulations and filings
- Edit and independently prepare regulatory communications; including memos, correspondence, and presentations
- Prepare and maintain annual renewals of pertinent domestic and international licensing
- Assess post-approval changes and provide high quality supplemental submissions to regulatory agencies as needed
- Ensure that development activities are aligned with regulatory requirements and project timelines are commensurate with regulatory filing objectives
- Manage relationships with third parties, including distributors and vendors, for projects requiring submission of data to regulatory Agencies
- Prepare and maintain database of all label text files approved by worldwide regulatory bodies
- Provide support to the Quality function through change control assessment and label review activities
- Liaise with necessary cross-functional areas, partner(s) and relevant parties (including vendors and distributors) to proactively and collaboratively resolve regulatory issues that may impact the projects
- Create/maintain regulatory SOPs, assisting with internal self-audit
- Lead regulatory remit for promotional/non-promotional material review, including websites, and product information/risk minimization material dissemination to HCPs and patients where required
- Create and maintain a matrix for each commercial product of regional differences from worldwide core dossier and label requirements.
Skills and Requirements:
- A Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life sciences is required.
- Ideal candidates will have a broad regulatory background, with experience of negotiating with EU regulators within Centralised/De- centralised/MRP procedures, as well as familiarity with Rest of World filings through affiliates/partners.
- The successful candidate will have had a breadth of experience with 5+ years of Regulatory Affairs experience in a pharmaceutical company involved with marketing, life cycle management, development, manufacturing, testing and distributing ethical pharmaceutical products.
- Additional experience in a smaller company is a plus.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Patrick Hale at +44 203 826 1331 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.