HRS Hyper Recruitment Solutions: Senior Regulatory Affairs Associate

We are currently looking for a Senior Regulatory Affairs Associate to join a leading Life Sciences company in Berkshire. The main focus of this role will be to provide Regulatory support to their busy project teams.

KEY DUTIES AND RESPONSIBILITIES:

The successful Senior Regulatory Affairs Associate will be expected to:

1. Support customers by providing Regulatory CMC sections in line with agreed timelines and scope.

2. Liaise with manufacturing Site (Development teams, MSAT, Engineering, Production, Quality, Customer Program and Contract Management in order to achieve required customer support.

3. Establish and maintain regulatory systems within the group to allow timely update of relevant regulatory dossiers.

4. Ensure regulatory compliance for manufacturing and testing activities at their facilities, including, but not limited to the UK and USA.

5. Assist Regulatory Affairs Group Head to expand the range of regulatory services currently offered to their customers, including, but not limited to provision of regulatory strategy services, provision of scientific advice documents.

6. Provide advice and information to customers and internal departments on regulatory guidance and regulatory compliance issues.

ROLE REQUIREMENTS:

The successful Senior Regulatory Associate will have a degree in a Life Science discipline as well as proven experience working within Regulatory Affairs, in particular within Biologics. You will have knowledge of legislation and GMP requirements for the development, manufacture and testing of biotechnology products. The Senior Regulatory Affairs Associate will have knowledge of CTD format for regulatory submissions into IND, IMPD, BLA and MAA format as well as an understanding of regulatory CMC requirements for different stages of biotechnology drug development. Experience of EU CTA, MAA and Scientific Advice procedures and knowledge of FDA, IND and BLA procedures, along with experience of preparing and submitting regulatory documentation are highly preferred.

Key Words: Senior Regulatory Affairs Associate, Biologics, FDA, MHRA, BLA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant 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 scientists supporting science. We look forward to helping you with your next career moves.

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