Regulatory Affairs Manager

GenèveFixeChimie, Pharma, Biotechnologie2019-04-26Non exigé / Non qualifié
We are recruiting a Regulatory Affairs Manager, minimum 8 years experience, to join a dynamic pharmaceutical company in Geneva

Regulatory Affairs Manager

Your Responsibilities

· Integration, creation and execution of multiple and complex global regulatory submissions and interactions with Health Authorities to support clinical trials, 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; identify relevant experts and/or writes position paper
· 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 packages.
· 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 minimisation material dissemination to HCPs and patients where required.
· Record and distribute minutes of project meetings to team members and stakeholders
· Create and maintain a matrix for international country regulations for product submissions
· Create and maintain a matrix for each commercial product of regional differences from worldwide core dossier and label requirements.

Your Profile

· A Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life sciences is required.
· A relevant graduate degree is preferred. 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 8+ 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.
· A strong working knowledge of International/Regional regulations and approval processes, and an excellent track record in building effective relationships with other departments and third parties.
· The successful candidate will be experienced in all components of regulatory submissions including Chemistry, Manufacturing and Control, non-clinical, and clinical documentation.
· Regulatory compliance management and sound knowledge of promotional/non-promotional material review/approval.
· Strong oral and excellent written communication skills are required.
· Travel up to 10% of the time.

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La référence de cette offre est JN -042019-295437