CRSF Regulatory Manager
GSK House, Brentford
Initial 4 Month Contract
Pay: up to £400 per day
We are offering a role for a highly motivated regulatory affairs professional responsible for coordinating the authoring and submission of Chemistry, Manufacturing, and Controls (CMC) variation packages. You would have responsibility for the coordination of global CMC regulatory activities across different dosage forms for products of both local and regional opportunity (POLOs/POROs). You would be expected to motivate staff within and across departments on assigned tasks. You can play a key part in GSK’s commitment to making a difference to patient’s lives.
- Advise and coordinate between both GSK and contract packaging sites and local Regulatory teams to support the successful implementation of child-resistant senior-friendly packaging to GSK’s POLO/PORO products within designated timeframes.
- Interpret and advise on regulatory guidelines, procedures and policies to deliver the optimal regulatory strategy. This will ensure that information submitted in variations meets regional requirements allowing maximum manufacturing flexibility with minimal unanticipated questions.
- Ensure that the strategy is aligned to that being implemented by the Global Regulatory CMC team for non-POLO/PORO products
- Responsible for the accuracy of regulatory planning data for POLO/PORO CRSF Programme and for providing information to support the CRSF Pharma Regulatory S&OP Process.
- Maintain high quality standards and behaviours including being customer driven, using flexible thinking and with continuous improvement approaches.
- Highlight potential delaying factors promptly to line management
- Share knowledge of regulatory documentation and procedures with others to assist in problem solving.
- Degree holder - Pharmacy, chemistry or related scientific discipline or equivalent qualification
- CMC regulatory affairs and knowledge of drug development and/or manufacturing and supply processes.
- Detailed knowledge of worldwide CMC regulatory requirements.
- Successful track record of managing projects.
- Excellent team working abilities and effective influencing skills
- Demonstrated ability to handle complex global CMC issues through continuous change improvement
- Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
- Experience of evaluation and provision of CMC Regulatory advice for the implementation of child-resistant senior-friendly packaging to GSK’s products.
- Involvement in / leading business critical activities within and external to the organisation.
- Demonstrated ability to motivate and lead others
- Successfully influenced and negotiated issues with regulatory agencies
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.