Senior Regulatory Affairs Associate

3 days ago


Cambridge, United Kingdom Hays Specialist Recruitment Limited Full time

Senior Regulatory Affairs, contract job, Emerging Markets, virology, Asia, LATAM, Africa, Middle East, EEU
Senior Regulatory Affairs Associate - Emerging Markets
**Your new company
**This well known biopharmaceutical company are looking for an experienced Regulatory Affairs Associate for a 12 month Senior Regulatory Affairs Associate contract job, this contract job has scope for extension
**Your new role
**As Senior Regulatory Affairs Associate contractor you will join the Virology Team to support regional activities across the IC & GPS (Intercontinental and Global Patient Solutions) region which includes territories throughout Asia, Latin America, Africa,Eastern Europe and the Middle East.
The team provides strategic and technical advice from development throughout the whole product lifecycle for all HIV, Hepatitis and Emerging Viruses projects/products. The team's core activities are to plan, prepare and progress new product registrations andsubsequent post-approval safety and indication updates
As Senior Regulatory Affairs contractor you will be responsible for supporting post-marketing activities for the preparation of regulatory submissions in IC/GPS markets, which may include, but is not restricted to variations, PSURs/RMPs, responses to questionsand renewals. You will also prepare and maintain labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner in the impacted local market
**What you'll need to succeed**
**What you'll get in return**
Flexible working options available.
**What you need to do now**
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.



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