Are you looking for an exciting new career opportunity?
Invenia Group has partnered with a fast-growing, award-winning pharmaceutical company, looking to hire a Regulatory Associate to its team of experts.
Role responsibilities:
As a Regulatory Associate, you’ll play a critical role in ensuring compliance with global regulatory requirements. You will support the development, preparation, and timely submission of regulatory documents and assist in maintaining regulatory compliance and supporting cross-functional collaboration across departments. You will also:
- Perform technical evaluations
- Support lifecycle management activities for approved products
- Monitor and track regulatory submission statuses of pending submissions and coordinate internal teams to ensure timely and accurate responses to regulatory authority queries
- Coordinate internal review and approval of regulatory documents and submissions
- Collaborate with cross-functional teams to gather data for submissions
- Stay current with FDA regulatory guidelines and industry best practices
- Contribute to the continuous improvement of regulatory processes and templates.
What we are looking for:
We are looking for someone with a Bachelor’s degree in life sciences, pharmacy, or a related field, and at least 1-3 years of experience in regulatory affairs within the pharmaceutical industry is preferred. You should:
- Have an understanding of FDA regulations and guidance, including eCTD format and submission processes
- Familiarity with US and global regulatory environments
- Regulatory Affairs Certification (RAC) is a plus
- Strong attention to detail and ability to manage multiple projects and deadlines
- Excellent written and verbal communication skills
- Proficiency in Microsoft Office and regulatory submission software
- Ability to work independently and collaboratively in a fast-paced, team-oriented environment.
Sound interesting? To find out more information regarding this opportunity, please apply.
