Senior Regulatory Affairs Manager

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 our clients regulatory project team representing Middle East Africa, Turkey, CIS & Russia and Central Eastern European Markets in the International Growth Markets team with accountability for 1-3 products progressing through NDA planning, filing and approval.

This is a contract position, offered initially for 6 months, working 37.5 hours per week. (Preferably 2 days a week in the office / Inside IR35).

Responsibilities:

Provides regulatory support to IGM Cluster Head for new regulatory filings with specific individual accountability for development of NDA submission and major line extension including labelling strategies and execution
Manages the communication, development and implementation of NDA and major line extension strategy assigned product(s) in Middle East Africa, Turkey, CIS & Russia and Central Eastern European Markets
Working closely with global, regional and in-country regulatory teams
Responsible for development and delivery of regulatory strategy for assigned products
Working closely with partner and affiliate counterparts, supply chain, PV, commercial and medical colleagues where required to determine optimal NDA filing and launch strategy
Ensuring delivery of strategy to the timelines agreed working in partnership with CRO
Regional Strategy lead for assigned products providing regional insights
Attend and contribute to other various cross-functional forums, including launch meetings
Taking time to review root cause and proposing/looking for improvements to our current systems and process, to improve our performance and consolidate IGM within the global organisationExperience and skills:

BA/BS/University degree required - Life/Health Sciences preferred
Minimum 5+ years pharmaceutical/biotechnology industry experience in Regulatory Affairs, ideally in International/Emerging Markets
Skills and experience to represent the Region and IGM group on project teams.
Experience and knowledge in the preparation of NDA submissions in the IGM region
Good knowledge and understanding of international regulatory affairs

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