Posted in Science 30+ days ago.
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Location: King of Prussia, Pennsylvania
Position Title: Regulatory Manager/Associate Director - Biopharm CMC Regulatory Affairs
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: Not Indicated
Required Education: Bachelors
Travel Required: 0%
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 Merion, 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.
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.