Regulatory Affairs Officer

Location
London
Salary
Dependent on experience
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
J5634412
Contact
Debra Fong
Contract Type
Permanent
Hours
Full Time
Are you an experienced Regulatory Affairs Officer looking for an exciting new challenge?

We are currently looking for a Regulatory Affairs Officer to join a leading animal health company based in the Greater London area.

As the Regulatory Affairs Officer you will join the Regulatory Life Cycle Management team and be responsible for managing the preparation, submission and tracking of applications and approvals for veterinary products to ensure compliance with country specific regulations.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:

1. You will be responsible for managing the international applications and post marketing submissions in accordance with local legal requirements to the required standard as well as manage and communicate dossier module variations/labelling updates where required.

2. Additionally, you will also be responsible for operating the electronic submission portals, assess regulatory intelligence to identify impact upon internal processes and undertake gap analysis of key technical documents and identify potential challenges.

3. As the Regulatory Affairs Officer, you will also be managing and communicating dossier module variations / labelling updates and also co-ordinate with functional team members to address national requirements.

4. You will manage data input to the Regulatory Information Management Systems (RMS), ensure data integrity and provide relevant reports as requested and also manage the update and import of RA documents to SharePoint.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior / Regulatory Affairs Officer we are looking to identify the following on your profile and past history:

1. Relevant Life Sciences degree and experience in a Regulatory Affairs role is essential for this position. Experience in animal health industry is preferred, but will not rule out other industries such as pharmaceutical / medicine.

2. Experience of regulatory operations (managing electronic data management systems) is also required.

3. Strong organizational skills and the ability to work well both within a multi-disciplinary team and independently.

Key Words: Regulatory Affairs | Pharmaceuticals | Life Science | Animal Health | Medicines | Quality Assurance | Pharmacovigilance | Quality | CMC

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.


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