Prin. Scientist, (Director) Regulatory Affairs-CMC

MSD • Rahway, NJ

1d • $190,800 - $300,300 • Hybrid

About The Position

The Regulatory CMC Principal Scientist is responsible for developing and implementing CMC regulatory strategies for pharmaceutical products in accordance with global regulations, guidance, and our company’s procedures. He/she will lead the preparation and submission of CMC dossiers to support global market applications. Our Regulatory Affairs team bring 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.

Requirements

• Proven experience in regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data is required.
• In-depth of experience in defining global CMC strategy and must have collaboration and decision-making capabilities to be successful in this role.
• Subject Matter Expertise in a pharmaceutical-related discipline.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
• B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry
• 5-10 years of pharmaceutical development experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
• At least 7 years' experience in Regulatory CMC roles, leading the preparation of NDA/MAA CTD content.
• The candidate must be proficient in English; additional language skills are a plus.

Nice To Haves

• additional language skills are a plus

Responsibilities

• Serve as a CMC Product Lead for new small molecule and peptide pharmaceutical products and be accountable for the delivery of all regulatory milestones throughout product development including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of new product submissions.
• Provide regulatory leadership, oversight, and strategy to a matrixed team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule and peptide development products. This includes preparation of applicable IND/CTAs, Agency Background Packages, and Worldwide Marketing Applications (including Most of World applications).
• Provide regulatory leadership as needed in product in-license/due diligence review
• Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed.
• Continuously evaluate and develop talent within the team and prepare a succession plan.
• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our company pharmaceutical products worldwide.
• Conduct all activities with an unwavering focus on compliance.

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

What This Job Offers

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