Regulatory Manager/Associate Director - Biopharm CMC Regulatory Affairs
Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and Global Manufacturing and Supply to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and Advanced Manufacturing Technology for multiple modalities for small and large molecules through to Cell and Gene Therapy. The Manager/Associate Director will lead key, strategic CMC regulatory activities for investigational and/or commercial biopharmaceutical (therapeutic protein and cell & gene therapy) products.
The successful candidate will:
• Represent Biopharmaceutical CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to product development teams and the global manufacturing organization.
• Be responsible for the global CMC regulatory activities for projects teams, setting the strategy for CMC regulatory content of clinical trial applications and marketing applications.
• Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of Biopharmaceutical and/or Cell & Gene Therapy products.
• Support license maintenance, change control requests, and post-approval submissions, ensuring delivery to agreed timelines.
• Maintain high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment.
• Communicates across the company to influence CMC project and policy issues that are aligned with business needs.
This role would suit a self-motivated individual who can demonstrate initiative, high learning agility and adaptability. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset.
The role would also suit an individual who has experience of working in a cross-functional, global supply organization. During the application process, we are looking to see that applicants have a clear understanding of the complexities and importance of supporting production within a pharmaceutical manufacturing process.
This role can be based in or Upper Providence, Pennsylvania, USA or Ware, Hertfordshire, UK this role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity.
• Bachelor's degree in life sciences or related field.
• CMC Regulatory Affairs or CMC development experience in Biopharmaceuticals or Cell & Gene Therapy gained with direct involvement in regulatory submission preparation.
• Experience of authoring or preparing and submitting CMC content for clinical trial applications and/or marketing applications.
• Successful track record of delivering CMC strategies and submissions content that comply with global regulatory requirements.
• Excellent team working abilities and effective influencing skills.
• Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
• Strong verbal and written communication skills with good attention to detail.
• Capable of working and making decisions independently.
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
We want to help people do more, feel better, live longer
We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.
As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, 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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