Director – Regulatory CMC

Director – Regulatory CMC

Requirements

• Post Graduate degree with 10+ years of experience or a Bachelor’s degree with 12+ years of experience in a relevant experience in regulatory affairs, with a focus on CMC aspects of pharmaceutical products.
• Strong understanding of regulatory guidelines and regulations related to CMC aspects of pharmaceutical products, including experience with regulatory submissions and interactions with regulatory agencies.
• Experience managing and leading a team of regulatory affairs professionals.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
• Strong attention to detail and ability to work independently.

Responsibilities

• Develop and implement regulatory strategies for CMC aspects of our pharmaceutical products, including preparing and submitting regulatory submissions to regulatory agencies.
• Interact with regulatory agencies to ensure compliance with regulatory guidelines and regulations related to CMC aspects of pharmaceutical products.
• Manage a team of regulatory CMC professionals and provide guidance and support for regulatory affairs activities.
• Collaborate with cross-functional teams to ensure regulatory compliance and timely product development.
• Keep up-to-date with current regulatory requirements and guidelines related to CMC aspects of pharmaceutical products.
• Provide strategic input on CMC aspects of product development and ensure that development plans meet regulatory requirements.
• Manage and oversee CMC-related activities for regulatory inspections and audits.
• Participate in the development and implementation of regulatory policies and procedures related to CMC aspects of pharmaceutical products.

Preferred Qualifications

No preferred qualifications provided.