HRS Hyper Recruitment Solutions: Senior CMC Regulatory Affairs Officer

We are currently looking for a Senior CMC Regulatory Affairs Officer to join a leading Biopharmaceutical company in the North West of England on a permanent basis.

ROLE OVERVIEW:

The successful Senior CMC Regulatory Affairs Officer will be assisting in the preparation of biopharmaceutical CMC submissions for global regulatory agencies. In addition to this you will be providing technical regulatory expertise in assessing proposals for manufacturing change (change controls) affecting clinical development biopharmaceutical products.

KEY DUTIES AND RESPONSIBILITIES:

As a Senior CMC Regulatory Affairs Officer your day to day tasks will be varied and will see the successful candidate doing the following:

1. Liaise with manufacturing, outsourcing, quality and development teams to ensure regulatory submissions are of appropriate quality and correctly schedules to meet business objectives.

2. Preparation and maintenance of CMC sections for INDs and IMPDs. In addition, preparation and maintenance of CMC CTD dossier for product licenses.

3. Assist the company in identifying the regulatory requirements of new acquisitions. Also assist with due diligence activities for potential in-licensing opportunities for brand products and evaluate dossiers.

4. Assist in development and maintenance of detailed plans for regulatory activities for the company licenses and assist in compiling responses to regulatory questions.

ROLE REQUIREMENTS:

To be successful as the Senior CMC Regulatory Affairs Officer we are looking for somebody who can hit the ground running in this role. To do so we are looking for applications for those that ideally have the following:

1. Degree in a Life Science discipline (or equivalent professional experience).

2. Experience of working in a Regulatory Affairs role within the Pharmaceutical or Biopharmaceutical industry.

3. Experience in the preparation of Module 3 CMC as well as Biopharmaceutical IMPD/IND preparation and maintenance experience.

4. Background in biopharmaceutical manufacturing process development and / or operations in drug substance manufacturing, preferably also some drug product manufacturing experience.

Key Words: Regulatory Affairs, CMC Module 3, Biopharmaceutical, IND, IMPD

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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