Development & Regulatory Chemist

Job Title:                   Development & Regulatory Chemist                         

Apply fast, check the full description by scrolling below to find out the full requirements for this role.

Reporting to:            Technical Manager, RNL

Location:                   RNL, Bury Mead Road, Hitchin

Working with:           R&D, BD, QC, QA, Production, Supply Chain.

Job Purpose:             To support the following key areas of the business:

1. New Product Development
2. Analytical Method and Process Validation
3. Technical documentation, including maintenance of existing ASMFs and development of new ASMFs

A wide-ranging role working as a key part of the R&D Team to support existing product registrations and develop new products to help the Company meet growth goals and meet expectations of regulators and customers.

JOB DESCRIPTION                                     

Accountabilities:

·        Development of new botanical extracts for use as pharmaceutical excipients and active ingredients to meet business development goals.

·        Maintenance of current ASMF filings.

·        Development of ASMF dossiers for new and existing products.

·        Supporting the commercial team in customer interactions.

Skills Profile:            

• Experience of development and/or analysis of botanical extracts for pharmaceutical or nutraceutical use
• Knowledge of validation of analytical methods to current pharmaceutical requirements
• Awareness of regulatory environment for active pharmaceutical ingredients
• Good general education with a practical approach and an ability to follow written & verbal instructions.
• Excellent communication skills and an ability to write technical documentation suitable for direct regulatory submission.

Key Performance Indicators:

• Compliance to set key project milestones.
• Management of requirements to maintain product lifecycles.

Person Profile:          

Good communicator with excellent organisation and prioritisation skills.

First class technical writing.

Team player with good independent working skills. xwzovoh

Interest in the promoting the use of botanical extracts in pharmaceutical products.