Regulatory Affairs Senior Manager - CMC

Planet Pharma is seeking a highly skilled regulatory affairs candidate with strong Chemistry, Manufacturing, and Controls (CMC) experience, particularly in preparing documentation for both Clinical Trial Applications (CTAs) and Marketing Authorization Applications (MAAs).

🎯 Purpose of the Role

• Deliver high-quality CMC regulatory services to support global pharmaceutical development and commercialization.
• Manage multiple projects with accountability for execution, timelines, and stakeholder satisfaction.
• Collaborate with cross-functional teams to support development programs through to license submission and approval.
• Provide regulatory support for established products, including submissions in growth markets and post-approval activities related to drug substance and drug product.

🛠️ Key Responsibilities

Regulatory Affairs

• Ensure timely, high-quality regulatory deliverables across multiple projects and products.
• Proactively identify and mitigate regulatory risks for both development and marketed products.
• Provide expert CMC regulatory guidance to internal project teams.
• Maintain strong knowledge of global quality guidelines and their practical application.

CMC / Quality

• Define and implement CMC regulatory strategies for assigned projects and products.
• Lead the preparation and review of CMC documentation, including Module 3 sections.
• Participate in regulatory meetings to resolve CMC/Quality-related issues.
• Evaluate and act on proposed changes from QA/manufacturing, ensuring regulatory compliance.
• Coordinate with affiliates and distributors in emerging markets to address CMC regulatory matters.

Process Improvement & Innovation

• Assess and enhance CMC regulatory processes to improve operational efficiency.
• Contribute to patient-centric initiatives by proposing regulatory approaches aligned with healthcare values.

Person Specification

🎓 Qualifications & Education

• Bachelor’s degree in Chemistry, Biological Sciences, Pharmacy, or a related discipline.
• Advanced degree preferred (e.g., MSc, PharmD, PhD, JD in life sciences).

📚 Experience

• Proven experience in CMC regulatory affairs, with additional exposure to R&D, Manufacturing, QA, or QC.
• Solid understanding of formulation and analytical development in R&D.
• Familiarity with drug substance manufacturing principles (chemistry/biochemistry).
• Experience in developing solid and/or parenteral dosage forms, including process validation.
• Prior engagement with regulatory agencies, including briefing document preparation and participation in agency meetings.

🧠 Skills & Competencies

• Strong scientific communication skills; able to defend regulatory positions effectively.
• Skilled in navigating conflicting guidance and delivering practical solutions.
• Adaptable and resilient in dynamic environments.
• Excellent organizational and time management abilities.
• Confident in interactions with regulatory authorities.
• Capable of managing multiple projects and tasks concurrently.
• Comfortable working within a matrixed organizational structure.