Director, Regulatory Affairs, CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and implement CMC regulatory strategies for both clinical and commercial development as well as lifecycle management.

• Oversee the preparation of top-tier global Regulatory CMC submissions, including IND, IMPD, BLA, MAA, and post-approval supplements.

• Act as the Regulatory CMC representative on project teams, providing strategic regulatory insights.

• Collaborate with teams across CMC, Supply Chain, Quality, and Regulatory Affairs to execute regulatory strategies.

• Organize and engage in Health Authority meeting requests, briefing documentation, and responses to inquiries.

• Evaluate CMC sections of regulatory submissions to ensure compliance and strategic coherence.

• Lead and take part in regulatory discussions with Health Authorities.

• Create Regulatory CMC strategies and conduct risk assessments for designated projects.

• Identify ongoing process enhancements and involve relevant teams and stakeholders.

• Interpret global CMC regulations and guidelines for Summit staff.

• Assist during Health Authority inspections.

• Report regulatory compliance issues to CMC RA Management.

• Keep abreast of current global CMC regulations and guidance.

⛳️ Requirements

• A Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry, or a related scientific field is required.

• A minimum of 10 years of experience in Regulatory CMC and/or related roles within the Pharmaceutical industry is required.

• Experience in biologics is necessary.

• Comprehensive knowledge of FDA, EU, and global regulations is essential.

• Significant experience in developing regulatory strategies for complex products is required.

• Proven experience in preparing CMC sections for intricate regulatory submissions.

• A solid understanding of IND, CTA, BLA, and MAA processes is critical.

• Experience in engaging with health authorities regarding regulatory CMC matters is required.

• Proficiency in spoken and written Mandarin Chinese is highly desirable.

• Familiarity with Microsoft Office Suite, electronic document management systems, and document review tools is advantageous.

• Strong computer and database skills are necessary.

• Meticulous attention to detail, accuracy, and confidentiality is essential.

• Excellent oral and written communication skills are required.

• Superior organizational abilities are necessary.

• Strong critical thinking and problem-solving skills, with the ability to work autonomously, are essential.

• Capability to multitask and manage time-sensitive, highly confidential documents is required.

• Ability to articulate complex ideas clearly is a must.

• Proficiency in prioritizing conflicting demands is required.

• Ability to thrive in a fast-paced, challenging, and collaborative environment is essential.

🏝️ Benefits

• The total compensation package may encompass bonuses, stock options, benefits, and/or other applicable variable compensation.

• Commitment to Equal Opportunity Employment and non-discrimination in recruitment, hiring, training, and promotion.