Senior Associate Regulatory Affairs

Senior Regulatory Affairs Associate

Part office, part home based to start with, but prepared to be flexible for the right person, so could accept someone that wants to be fully remote.

Cambridge or Stockley Park location would be ok
12 months contract

£52.5 per hour maximum pay rate

Description


We have an exciting opportunity for a Senior Regulatory Associate (12 month contract) to join the Global Regulatory Affairs Virology Team to support regional activities across the ACE (Australia, Canada, Switzerland, GB and EU) region and 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 and subsequent post-approval safety and indication updates. We work cross-functionally with a diverse number of stakeholders both internally and externally. The team works on a broad portfolio of products and can offer the opportunity to work on a diverse range of regulatory activities. The team and regulatory department as a whole is built on a strong sense of team work.

Essential Duties and Job Functions

• 
  Responsible for supporting regulatory strategies and preparing submissions for designated products in these 2 regions. These activities range from new product licenses to lifecycle activities and support all regulatory aspects of the application.
  
  * Support post-marketing activities for the preparation of regulatory submissions via the EU centralised procedure, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.
  
  * Support post-marketing activities for the preparation of regulatory submissions in given markets outside of the EU, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.
  
  * 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.
  
  * Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in designated territories including the co-ordination of labelling translations as required.
  
  * Support the preparation/ maintenance of clinical trial applications.
  
  * Represent the Regulatory Affairs function at cross functional submission/ study management team meetings.
  
  * Participate in RA team meetings, product team meetings and departmental meetings.
  
  * The person in this role will have an understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
  
  * Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
  
  Key role-related competencies
• 
  Able to facilitate/impact and influence effective interactions and discussions
  * Able to effectively interact to information gather and effectively drive projects through to completion to tight timelines.
  * A good scientific background and understanding
  
  Education and/or Experience required
• 
  Life sciences degree
  * Relevant experience in Regulatory Affairs
  * An understanding of regulatory requirements for the EU centralised procedure
  * Experience in supporting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc for Centralized products is desirable.
  * Experience with working with document management systems (RDMS / SIMS).
  
  Core competencies
• 
  Excellent oral and written English communication skills
  * Excellent planning and organizational skills with the ability to work simultaneously on a number of projects with tight timelines
  * Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
  * Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
  * Problem solving, strategic thinking skills with ability to impact and influence
  * Attention to detail with accuracy and quality
  * Ability to understand and effectively relate to external and internal customers
  * Business awareness and professionalism