COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.
This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. We are currently experiencing substantial growth in our regulatory team and as a result we are looking to hire an additional Associate I in Regulatory Submissions. This is a very exciting time for Covance and the team. In this role you will have a great opportunity to progress and develop in your career. This role will be based in Maidenhead.
About the Job
This is an exciting opportunity to join the Regulatory team with responsibility for submissions to the Regulatory Authorities making sure the required standard is met, this varied role will include:
Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs)
Contribute to the preparation of submissions to Health Authorities by reviewing/summarising scientific/research documents
Assist in the coordination, collection and organisation of information required by Regulatory Authorities
Interact with the Copy Center or equivalent as necessary for the publishing of submissions
Maintain knowledge and awareness of regulations and guidelines pertaining to drugs and biologics
Monitor compliance with regulatory requirements in relation to assigned projects
Bachelor’s Degree in Life Sciences or equivalent
Ideally at least 12 months of relevant work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA.
Previous regulatory affairs experience would be highly beneficial. Typically 6 months to 1 year.
Excellent communication, organisational and time management skills
Self motivated with the ability to work under pressure
Works well in a team as well as independently
Positive attitude and approach
Computer literate with Microsoft Office suite
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Education/Qualifications See above Experience See above EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Covance - 11 months ago