Associate Principal Scientist, Global Vaccines Chemistry, Manufacturing and Control

Merck • North Wales, PA

5d • $142,400 - $224,100 • Hybrid

About The Position

This Role is responsible for developing and implementing Chemistry, Manufacturing and Control regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies, in addition to the preparation and review of information required for development of regulatory Chemistry, Manufacturing and Control dossiers for commercial products. Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

Requirements

• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., manufacturing, analytical testing, and quality assurance).
• Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems including Veeva.
• Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Demonstrated effective leadership, communication, and interpersonal skills
• Bachelor's in science, Engineering, or a related field (advanced degree preferred but not required). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
• Adaptability
• Biologics License Application (BLA)
• Cross-Cultural Awareness
• Detail-Oriented
• Electronic Common Technical Document (eCTD)
• Employee Training Programs
• International Regulatory Compliance
• Pharmaceutical Process Development
• Regulatory Affairs Management
• Regulatory CMC
• Regulatory Strategy Development
• Regulatory Submissions
• Regulatory Writing
• Strategic Thinking
• Technical Writing

Nice To Haves

• Advanced degree preferred but not required.
• At least 5 years pharmaceutical industry experience, or up to 3 years' experience in managing Chemistry, Manufacturing and Control Regulatory submissions for small molecules/vaccines/biologics.
• Experience in Veeva.

Responsibilities

• Lead global product and project regulatory strategies by identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Execute regulatory strategies by leading the development, authoring and review of Chemistry, Manufacturing and Control submission components and documentation to support approval supplements/variations, Drug Master Files, New Drug Application/Biologics License Application/Marketing Authorization Application, Annual Reports, Commitment and responses to health authority questions.
• Liaise with global Chemistry, Manufacturing and Control, Manufacturing Division and external partners including Contract Manufacturing Organizations to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones for assigned products across the product lifecycle.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior