Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives.
Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for small and large molecules.
The Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biological products.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Leads CMC regulatory activities for investigational, late development and/or early commercial GSK products.
Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development, registration, and lifecycle maintenance submission content in accordance with the applicable regulatory and scientific standards, and 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.
Serves as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
May have direct line management responsibility or act as individual contributor.
May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
Delivers CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).
Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK.
Impact of Decisions
Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biopharmaceutical products, to expedite submission, review and approval of global CMC applications.
Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
Problem Solving
Directs project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provides strategic direction, data assessment and conclusions to senior management.
Formulates novel approaches and influences people, systems, and processes.
Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies.
Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems.
Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelors degree in a Biological sciences area.
7 + years of direct CMC Regulatory experience.
Experience leading key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals.
Experience working in large enterprise company leading complex projects.
Experience working with new drug applications in the US or EU.
Experience creating Regulatory strategy and executing on those plans.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Advanced biological sciences degree.
5 +years CMC Regulatory project leadership experience with biological medicines. (Therapeutic proteins and/or cell & gene therapies).
Ability to demonstrate flexible thinking and high resilience in the workplace.
Ability to work with frequent changing priorities within a fast-paced work culture.
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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