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 standards
Experience 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.
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.
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