Are you an experienced Regulatory Affairs Principal Associate looking for an exciting new job opportunity?
We are currently looking for a Regulatory Affairs Principal Associate to join a leading pharmaceutical company based in the West Yorkshire area.
As the Regulatory Affairs Principal Associate you will be responsible for the hands on regulatory activity required to submit, approve and launch new products as well as the maintenance of existing commercialised products.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Principal Associate will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for the execution of regulatory activities to meet current legislation and local laws as per the project plan to assure new products meet submission, approval and commercial launch goals.
2. You will review and approve documentation prepared by internal & external stakeholders, independently using regulatory knowledge and guidelines to ensure compliance for new marketing authorisations, including marketing materials.
3. As the Regulatory Affairs Principal Associate, you will also ensure regulatory files and data systems are maintained in compliance with SOPs and KPIs in line with business goals as well as ensure compliance with appropriate global legislation governing regulatory, safety, manufacturing and distribution of product resulting in no interruption to flow of business or impact on company reputation.
4. You will be representing and negotiating for regulatory affairs in project meetings with internal & external stakeholders. As a product owner, independently providing comprehensive and detailed regulatory advice to support the business including change control SME.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Principal Associate we are looking to identify the following on your profile and past history:
1. Relevant Life Sciences degree and extensive experience working in a regulatory affairs position within a pharmaceutical company is essential for this role as you will need to have a good understanding of regulatory legal basis licensing requirements in particular generic submissions.
2. The Regulatory Affairs Principal Associate will have detailed CMC knowledge and a general understanding of bioequivalence. Any knowledge of formulation development proves advantageous.
3. Starting to develop managerial skills with evidence in problem solving, prioritisation of goals and stating to provide easy strategies for general stage gate products.
Key Words: Regulatory Affairs | Principal | Manager | CMC | Pharmaceutical | Formulation Chemistry | Life Science
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.