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Regulatory CMC Strategy Manager

2 months ago

London, Greater London, United Kingdom Pfizer Full time
Job Description

Pfizer is seeking a highly skilled Regulatory CMC Strategy Manager to join our team. As a key member of our global regulatory affairs team, you will play a critical role in ensuring the successful development and approval of our pharmaceutical products.

Key Responsibilities:
  • Collaborate with cross-functional teams to progress Pfizer's business objectives and align expectations.
  • Manage planning and monitoring activities to mitigate risks and contribute to global regulatory strategies.
  • Develop and implement regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.
  • Provide guidance and lead/co-lead projects, manage own time to meet objectives, and plan resource requirements.
  • Develop CMC documentation, coordinate and manage global submissions, and maintain product compliance.
  • Contribute to Global Chemistry Manufacturing and Controls projects, initiatives & actions, and prioritize assigned workload.
  • Investigate opportunities for regulatory innovation and promote the use of novel approaches within project teams.
  • Develop effective relationships with internal partners and leverage technical and regulatory knowledge to develop regulatory strategies and mitigate risks.
  • Execute regulatory policies and operational processes and deliver high-quality regulatory submissions.
Requirements:
  • Bachelor's Degree
  • Min 5+ years of experience in pharmaceutical or medical device industry
  • Min 3+ years of relevant pharmaceutical/medical device/IVD or combination product development and/or manufacturing experience
  • Skills and relevant experience that demonstrate CMC regulatory and quality expertise
  • Demonstrated commitment to scientific and regulatory integrity, quality compliance
  • Adaptable and self-motivated, able to prioritize effectively with strong problem-solving and planning abilities
  • Excellent planning, organizational, and project management skills
  • Advanced skills in written and verbal communications
  • Competent working knowledge of computer-based systems, such as Microsoft Office, controlled documentation systems
Preferred Qualifications:
  • Hands-on CMC authoring experience (investigational, initial registrations or post-approval)
  • Relevant medical device/IVD/combination product experience
  • Understanding of the regulatory requirements and development expectations for medical device and combination products
  • Understanding of medical device design and development expectations and design control requirements
What We Offer:
  • Annual base salary range: $99,900.00 to $166,000.00
  • Participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary
  • Eligibility to participate in our share-based long-term incentive program
  • Comprehensive and generous benefits and programs to help our colleagues lead healthy lives and support each of life's moments