Description
My client, a smaller-sized generics company based in Dublin is looking for a Senior Regulatory Affairs officer. This is a contracting role and would offer a candidate who is already working in regulatory affairs, the chance to take the next step in his/her career and gain great experience in a company that are poised on the brink of expansion for a 6 month contract. This role will be working in the UK/Ireland team and will be focusing on CMC variations, SPC's, labeling and renewals.Role responsibilities:
*Effectively prepare submissions and regulatory documents including dossier sections and collate relevant information for CMC related variations
*Ensure accuracy, scientific validity and optimal presentation of submission documents
*Review proposed artwork components, approve print proofs for third parties and assist in their planned implementation
*Review SPCs and PILs and prepare relevant submission
*Follow up with the authorities to ensure submissions are resolved in a timely fashion and regulatory documents including dossier sections and collate relevant information for CMC related variations
Candidate requirements:
*MSc or BSc degree in a scientific discipline
*Ability to prepare high quality regulatory applications
*Ability to handle multiple tasks in a fast-paced and constantly changing environment
*Knowledge of drug development is desirable although not essential
If this role sounds like an ideal match for your skill set and career aspirations, please contact me Anna Mooney or apply below with an up to date CV.
To find out more about Real please visit www.realstaffing.com