Are you an experienced regulatory affairs associate looking for a new exciting job opportunity?
We are currently looking for a Regulatory Affairs Senior Associate to join a growing pharmaceutical company based in the West Yorkshire area.
As the Regulatory Affairs Senior Associate you will be responsible for the hands on regulatory activity required to submit, approve and launch new products with minimal and / or no supervision.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Senior Associate will be varied however the key duties and responsibilities are as follows:
1. You will assist in the execution of regulatory activities per the project plan to assure new products meet submission, approval and commercial launch goals. Including management of applications for new marketing authorisations (with minimal supervision) as per the relevant competent authorities requirements and in compliance to local laws and regulations.
2. You will be responsible for reviewing and approving variations strategies and documentation prepared by other members of the regulatory team as well as identify risks to the submission, engaging in proactive discussion with line manager, health authorities or other stakeholders to resolve any regulatory issues related to new marketing authorisations.
3. Additionally, as the regulatory affairs senior associate, you will also be an active participation as regulatory affairs representative in meetings with internal & external stakeholders, working cross functionally to achieve the business goal. As a product owner, providing comprehensive and detailed regulatory advice to support the business including change control SME.
4. You will also be responsible for developing and approving product information text in compliance with SOPs and relevant pharmaceutical guidelines for the new marketing authorisation.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Senior Associate we are looking to identify the following on your profile and past history:
1. A relevant Life Science / Pharmaceutical degree is required for this position.
2. Proven work experience in a senior regulatory affairs within the pharmaceutical industry is essential for this position as you will be expected to work with minimal / no supervision.
3. Industrial regulatory affairs experience for liquid dosage forms would be highly desirable and advantageous.