Project Manager – Regulatory Affairs

Job Summary
We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global regulatory frameworks, exceptional project management skills, and experience working with cross-functional teams to deliver regulatory affairs services in the pharmaceutical industry.

As a Project Manager, you will be responsible for overseeing the full lifecycle of regulatory projects, ensuring alignment with market standards, timelines, and quality requirements. This role requires strong leadership, strategic thinking, and the ability to collaborate with various internal and external stakeholders to drive the successful delivery of regulatory affairs objectives.

Key Responsibilities

• Project Management: Lead and manage regulatory projects (e.g., drug registrations, labeling updates, product lifecycle management) in accordance with regulatory requirements. Develop and maintain detailed project plans, including timelines, budgets, and resource allocation, to ensure successful project delivery. Coordinate with internal teams (Regulatory Affairs, Clinical, CMC, QA, etc.) and external stakeholders (regulatory authorities, vendors, partners) to ensure regulatory submissions are prepared accurately and on time. Monitor project progress, identify risks, and implement corrective actions to resolve any potential issues. Ensure all regulatory activities are executed in compliance with local, regional, and global regulations and guidelines.
• Regulatory Strategy & Compliance: Provide guidance on regulatory strategy for new product development, life-cycle management, and post-market compliance. Support the regulatory submission process by ensuring all required documents, data, and information are prepared, submitted, and tracked according to regulatory authority requirements. Maintain an up-to-date understanding of global regulatory changes (FDA, EMA, ICH, etc.) and their impact on the organization's products and projects.
• Cross-functional Collaboration: Work closely with R&D, quality assurance, manufacturing, and other departments to ensure regulatory considerations are incorporated throughout the product development lifecycle. Foster strong relationships with regulatory agencies and external partners to influence and expedite approval processes.
• Documentation & Reporting: Ensure that regulatory submissions, dossiers, and project documentation are organized, complete, and compliant with regulatory guidelines. Prepare and present regular project updates and reports to senior management and key stakeholders on project status, timelines, risks, and issues.
• Continuous Improvement: Identify areas for improvement in regulatory processes and propose solutions to increase efficiency and compliance. Drive regulatory best practices and ensure adherence to internal SOPs, industry standards, and regulatory requirements.

Qualifications

• Bachelor's or master's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• Certification in Regulatory Affairs (e.g., RAC) preferred.

Experience

• Minimum of 5-7 years of experience in Regulatory Affairs, with at least 3-5 years in project management in the pharmaceutical industry (CRO, Biopharma, or consulting firm experience preferred).
• Proven experience managing regulatory submissions (e.g., IND, NDA, MAA, etc.) in various regions.
• Strong understanding of global regulatory requirements, guidelines (FDA, EMA, ICH, etc.), and pharmaceutical industry standards.
• Demonstrated expertise in managing cross-functional teams, timelines, budgets, and project deliverables.

Skills

• Strong project management skills, including proficiency in project management tools (e.g., MS Project, Jira, etc.).
• Excellent written and verbal communication skills, with the ability to effectively interact with senior stakeholders and regulatory authorities.
• Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.
• Ability to navigate complex regulatory environments and provide clear regulatory guidance.
• Strong problem-solving skills, with the ability to assess risks and implement mitigation strategies.

Personal Attributes

• Leadership and team-oriented mindset.
• Strong analytical thinking and attention to detail.
• Ability to thrive in a fast-paced, dynamic environment.
• High level of integrity and ethical standards.
• Proactive and solution-oriented approach to problem-solving.

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