CMC Regulatory Project Manager

Are you looking for a role where you can be responsible for the CMC regulatory activities of multiple projects and dosage forms? If so, this could be an ideal opportunity for you to explore.

As a Regulatory Affairs Project Manager, you will represent Global CMC Regulatory on Regulatory Networks and Matrix Teams providing regulatory advice and guidance to

Preclinical Development (PCD), Biopharm, Global Manufacturing and Supply (GMS), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Office of the Chief Medical Officer (OCMO)

to produce appropriate CMC components for global regulatory dossiers with appropriate guidance from supervisor, as necessary.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
• Deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).Work with subject matter experts to map current and future processes, seek efficiencies, and integrate written standards and training requirements.
• Understand and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
• Ensure all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
• Ensure information submitted in marketing applications meets regional requirements, allowing maximum GMS flexibility with minimal unanticipated questions.
• Ensure all appropriate CMC regulatory aspects to support license maintenance and change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
• Manage multiple projects and teams simultaneously and provides data assessment and conclusions within and across departments.
• Formulate alternative approaches and influences people, systems and processes.
• Independently identify risks associated with submission data and information packages.
• Contribute to, and lead the creation, maintenance and continuous improvement of CMC Regulatory processes, policies and systems

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in Chemistry, Pharmacy or life science
• 5+ years of experience in the pharmaceutical industry
• Experience with worldwide CMC regulatory requirements

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Regulatory Affairs Certification (RAPS).
• Knowledge of drug development and manufacturing and supply processes.
• Experience with vaccines, large molecules, or biologics.
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Broad knowledge base across regulatory functions to understand wider implications of emerging issues across projects
• Experience in influencing and negotiating with GSK personnel in a variety of settings.
• Highly developed interpersonal, presentation and communication skills with established internal and external networks
• Successfully managed multiple projects simultaneously.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*LI-GSK

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