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.