Senior Associate, Regulatory

Are you looking for a new career opportunity?

Invenia Group has partnered with one of the fastest-growing pharmaceutical companies in the world, currently looking to hire a Senior Associate for its Regulatory Affairs team.

Role responsibilities:

As part of the Regulatory Affairs team, you’ll play a critical role in ensuring compliance with global regulatory requirements. You will support the development, preparation, and submission of regulatory documents to the US Food and Drug Administration (FDA) and other health authorities, as well as assist in maintaining regulatory compliance and supporting cross-functional collaboration across departments. You will:

• Prepare, compile, and submit regulatory submissions
• 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. You should have:

• 3-5 years of experience in regulatory affairs within the pharmaceutical industry
• Strong understanding of FDA regulations and guidance, including eCTD format and submission processes
• Familiarity with the 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? This is a fantastic opportunity to join a company that recognises that developing the skills and capabilities of employees is essential to achieving organisational goals. Apply today to find out more.