Introduction

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).

Your tasks

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.

Your profile

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.