Regulatory Affairs Cmc Manager, Mature Products

**Job Description**:

- We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. _
- We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. _
- Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK _

**Scope**

Responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products.

**In this role, you will**:

- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
- Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with mínimal unanticipated questions.
- Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
- Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
- Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
- Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
- Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

**_Why you? _**:
**Basic Qualifications**:
**We are looking for professionals with these required skills to achieve our goals**:

- Bachelor or Master Degree in life sciences or related scientific discipline.
- Regulatory Affairs Certification (RAPS).
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
- Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products.
- Fluent English both written and spoken.

**Preferred Qualifications**:
**Please note the following skills are not necessary, just preferred, if you do not have them, please still apply**:

- Good time management skills with the ability to effectively plan, prioritise and coordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.
- Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
- Strong interpersonal, presentation and communication skills with established internal networks.
- Proactively seeks out and recommends process improvements.
- Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
- Demonstrated ability to handle global CMC issues through continuous change and improvement.
- Developing experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).

**What we offer**:

- Permanent contract in a very Inclusive environment
- Smart Working up to 50% for eligible roles
- Performance Reward
- Flexible Benefits
- Company Healthcare Plan
- Integrative pension fund
- Employee Assistance Programme
- Prevention services and vaccination clinic
- Tax assistance
- Local nursery agreement
- Postal service, laundry, shoe repair and tailoring
- On Site Gym
- On Site canteens and coffee corners
- Free company bikes and shuttle

**Closing Date for Applications - 5th of November**
- Please take a copy of the Job Description, as this will not be available post closure of the advert. _

**#LI-Hybrid**
- At GSK, we have bold ambitions for patients,