Senior Manager, Gra, Cmc Vx Mature Products
il y a 1 semaine
Site Name:
Belgium-Wavre, Italy - Siena, UK - London - Brentford
Posted Date:
Apr
As a Senior Manager, GRA, CMC Vx Mature Products, you will be responsible for leads CMC regulatory activities in the late development and /or lifecycle management of GSK products.
- Drives the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements. Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies. Ability to play a key role in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management
- Mentors or trains staff. May have direct line management responsibility, and typically has significant line management experience. Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate. Provides strategic direction, data assessment and conclusions within and across departments. Able to establish organisational networks (internal and external) understanding departmental constraints/pressure within a highly complex organisation.
- Engages and may lead CMC Subject Matter Expert activities and typically has deep/specialised area of expertise, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).
- 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.
- Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work. Has the ability to play a key role in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management
- Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company. Typically has significant experience managing agency interactions and is comfortable taking opposing views/position and can do so assertively.
- Operates with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicates sensitive matters or those with potential for high business impact.
_ Why you?_
Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:
- BSc or PhD in Life sciences or related scientific discipline
- Detailed knowledge of drug development and manufacturing and supply processes.
- Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
- Proven project management and multitasking skills.
- Significant track record managing and directing multiple projects/teams.
- Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings.
- Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
- Ability to play a key role in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines marketed product support.
- Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies Has identified opportunities to further educate internal colleagues and formulate approaches to most effectively meet new requirements.
- Highly developed interpersonal, presentation and communication skills with established internal and external networks.
- Proven experience in supervising and training junior staff within an organisation and has the ability to motivate and lead others.
_ Why GSK?_
GSK i
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