Manager, CMC Regulatory Affairs, Open to flexible working
Are you a professional with CMC Regulatory Affairs experience looking to expand and grow in your career? We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our Biopharm CMC Regulatory Affairs Group. At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals and Cell & Gene Therapy products. This role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity. You will play a key part in GSK's commitment to making a difference to patients' lives enabling them to Do More, Feel Better and Live Longer.
If this sounds exciting, this Manager, CMC RA could be an ideal role to pursue.
As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms. As an example of current projects in the team include working on marketing authorizations for COVID-19 and oncology.
This role can be based at our sites at Ware, Hertfordshire or at Upper Providence, Pennsylvania, USA, however this role will interact across our global network.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Manage the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
- Strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and lifecycle activities.
- Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Represent Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing strategic direction and guidance to Preclinical Development (PCD), Biopharm, Pharma Supply Chain (PSC), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Global Regulatory and Quality (GRQ) on both global project and key strategic business initiatives.
- Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in biotechnology, chemistry, pharmacy or closely related science
- Detailed knowledge of drug development and manufacturing and supply processes.
- Detailed working knowledge of worldwide CMC regulatory requirements.
- Experience and ability to manage and direct multiple projects/teams.
If you have the following characteristics, it would be a plus:
- Successfully influenced and negotiated issues with regulatory agencies and GSK personnel in a variety of settings.
- Vaccines, Biologics, or Large Molecules
- Clinical Development knowledge
- Experienced in supervising and training junior staff and the ability to motivate and lead others.
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
- Demonstrated ability to handle complex global CMC issues through continuous change and improvement
Our values and expectations are 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, rigor 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.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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