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Senior Regulatory Affairs Manager
Job Posted: 2 days ago
Salary: £ Competitive
Job Type: Contract
Location: Maidenhead, Berkshire
Expire in: a month
Job Description
Are you an experienced Senior Regulatory Affairs Manager? Do you have experience in the International Growth Markets? If so, we would love to hear from you!
The successful candidate will become a member of the Global Regulatory Project team representing the international Growth markets with accountability for 1-3 marketed products across APAC, MART CEER and LatAm.
You will be developing and implementing regulatory strategies to support product lifecycle management, ensuring compliance with evolving global requirements. You will also provide strategic regulatory guidance to project teams and ensure availability of current regulatory documentation to support new submission and lifecycle management activities across all regions.
This is a contract position, offered initially for 12 months, working 37.5 hours per week. (Preferably 2 days a week in the office / Inside IR35).
Responsibilities:
Manages the communication, development, and execution of International Growth Market strategies for Safety Updates and lifecycle management (LCM) submissions across multiple regions for 1-3 products
Ensure effective cross-functional collaboration by leading and participating in regular meetings to facilitate the collaborative exchange of key project information and strategic alignment
Accountable for the development and execution of lifecycle management submissions packages across all IGM regions, ensuring compliance and strategic alignment
Collaborate closely with cross functional teams such as partners, affiliate counterparts, Artwork teams, and PV to establish optimal strategies that maintain supply continuity and prioritize patient safety
Ensure timely delivery of agreed regulatory strategies, meeting established deadlines and regulatory expectations
Oversee CRO activities to guarantee the efficient and timely preparation of submission packages, maintaining high-quality regulatory standardsExperience and skills:
BA/BS/University degree required - Life/Health Sciences preferred
Minimum 3-5+ years pharmaceutical/biotechnology industry experience in International/Regulatory Emerging Markets
Skills and experience to represent the IGM group on project teams
Experience and knowledge in the preparation of lifecycle management submissions
Good knowledge and understanding of applicable regions
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.
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