CMC Senior Regulatory Executive

CMC Senior Regulatory Executive

Contract: 12 months contract

Pay:£582.38 per day via umbrella (inside IR35)

Location: Brentford / hybrid role

Standard description on Senior Regulatory Executive Template

·       Accurately assessing the Chemistry, Manufacturing and Controls (CMC) regulatory impact to proposed changes.

·       Creation of efficient and robust strategic CMC lifecycle submission plans and overseeing the successful completion of the committed plan.

·       Preparation of high quality CMC detailed regulatory documents using varied information sources. Liaising closely with other GSK personnel to ensure accuracy of such records.

·       Working to agreed deadlines and maintaining records to reflecting project status

·       Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice

Required Skills

·       Minimum 3 years CMC regulatory experience

·       Strong written and oral communication and networking skills

·       Demonstrate ability to focus and work with attention to detail

·       Demonstrate ability to retain critical information

·       Strong and recent post-approval CMC experience with expert knowledge of the requirements to maintain a compliant marketing authorization application

·       Demonstrate team working and effective time management skills

·       Be a dynamic and highly motivated individual

·       Establish strong relationships and liaise effectively with GSK sites worldwide

·       Be proficient in the use of IT packages such as Word and excel.

·       Demonstrate problem solving skills

Below description added by Mature Products

Role Specific Requirements

·       Post Approval CMC regulatory experience: small molecule lifecycle management/change control experience, drug product and drug substance.

·       CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations.

·       Experience responding to manufacturing site change controls and providing CMC regulatory advice and strategies.

·       Detailed proven knowledge and experience of global CMC regulatory requirements.

·       Understands and can apply CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.

·       Ability to manage multiple project assignments simultaneously and provide data assessment and conclusions.

·       Identifies risks associated with submission data and information packages and ability to propose mitigation actions.

·       Ability to efficiently interact with customers and senior stakeholders as required

·       Identifies improvement opportunities for CMC Regulatory processes, policies and systems.

·       Good communication skills and flexible approach – “ can do attitude”

·       May contribute to process improvement and/or regulatory intelligence projects

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