Associate Principal Scientist, Regulatory Chemistry Manufacturing – Controls (CMC) Product Lead

This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

• Create and execute Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for designated small molecule or biological products.

• Oversee the preparation and submission of CMC dossiers for life-cycle maintenance submissions, initial registrations, and post-approval modifications.

• Act as the CMC Product Lead for assigned products, ensuring the achievement of all regulatory milestones throughout the product lifecycle.

• Direct global product and project regulatory strategies.

• Evaluate CMC changes, pinpoint global regulatory requirements, assess supporting documentation, and identify potential risks.

• Lead the development, writing, and review of CMC submission components and documentation.

• Assist with post-approval supplements, annual reports, registration renewals, and responses to inquiries from health authorities.

• Provide regulatory leadership for product in-license/due diligence assessments, product divestitures, and product withdrawals.

• Collaborate with Organon Manufacturing & Supply colleagues and external partners on compliant change management processes.

• Manage CMC documentation in accordance with established business processes and systems.

• Evaluate and communicate regulatory risks while proposing mitigation strategies.

• Identify, communicate, and escalate regulatory issues to Organon Regulatory CMC management.

• May supervise 1 to 2 individual contributors and/or outsourcing partners.

• Support project team objectives and organizational initiatives as required.

⛳️ Requirements

• Bachelor’s degree in a science, engineering, or related discipline with a minimum of 7 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related area.

• OR an advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of pertinent experience, including biological/pharmaceutical research, manufacturing, testing, or a related sector.

• Proficient in English; additional language skills are advantageous.

• Demonstrated experience in critically reviewing detailed scientific information and evaluating technical merits and scientific rationale.

• Excellent oral and written communication skills in multicultural environments.

• Capability to convey complex issues clearly and logically.

• Strong listening abilities.

• Solid understanding of related fields such as manufacturing, analytical processes, and quality assurance.

• Ability to devise creative and innovative approaches to diverse problem-solving challenges.

• Skill in generating novel solutions to complex regulatory issues.

• Competence in working with and communicating effectively with key stakeholders.

• Adaptability in responding to shifting priorities or unforeseen events.

• Strong leadership, communication, interpersonal, and negotiation skills.

• Ability to lead direct or matrixed colleagues to meet business commitments and project deadlines.

• Experience in Regulatory CMC post-approval lifecycle management is preferred.

• Must meet all applicable travel and credentialing requirements, including associated vaccination prerequisites.

• No visa sponsorship available.

🏝️ Benefits

• Retirement savings plan.

• Paid vacation and holiday time.

• Paid caregiver/parental and medical leave.

• Health benefits, including medical, prescription drug, dental, and vision coverage.

• Flex Time.

• Remote Work.