Regulatory Information Associate - United Kingdom
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- Across the globe, our company employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
- More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
- Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.
We make medicines that help people live longer, healthier, more active lives.
Integrity, excellence, respect for people
We will make a significant contribution to humanity by improving global health in the 21st century.
Purpose of the Job:
The purpose of the Regulatory Information Associate is to:
- Closely monitor global regulatory environment, and ensure timely provision of intelligence to GRA-International and relevant functions;
- Interpret European and other regulatory guidelines;
- Provide advice on regulatory issues.
Key Responsibilities :
- Closely monitor EU and other countries’ regulatory environments, and ensure timely provision of intelligence to relevant functions;
- Interpret legislation and guidelines and anticipate impact of new developments in these areas;
- Support for GRA-Int. management in membership of external groups/committees and in efforts to influence key legislation, including submission of comments on public consultations;
- Provide expertise on European registration and product regulatory strategies;
- Ensure provision of competitor intelligence to appropriate members of GRA-Int.;
- Initiate, develop and maintain relationships with key contacts at regulatory agencies and trade associations.
GRA-Int. information systems and information provision:
- Maintain and develop GRA-Int. website and information databases;
- Promote use of GRA-Int. website and information databases.
GRA-Int. business processes
- Assist with development of regulatory quality documents by GRA-Int.; input on behalf of GRA-Int. to regulatory quality processes and tools;
- Provide training to GRA-Int. scientists on relevant topics as needed.
Education and Experience
- Understanding and knowledge of European and other country regulations;
- An understanding of the cross-functional nature of drug development and regulatory implications;
- Computer skills (Word, Excel, PowerPoint).
- Ability to positively impact colleagues and teams;
- Assembles external resources to resolve regulatory issues as appropriate.
- Ability to work independently and in teams;
- Time management skills.
Communication skills: writing, presenting, listening.
Problem solving skills.
- An advanced degree in health or life sciences is preferred;Qualified candidates must be legally authorized to be employed in the United Kingdom.
- Our company does not anticipate providing sponsorship for employment visa status for this employment position.