Associate Director, Regulatory Affairs CMC

Essential Functions:

• Create optimal development paths for product candidates and negotiate with health authorities.
• Execute CMC submission and authoring strategy to ensure documents are high quality in content, organization, and accuracy.
• Incorporate global regulations and health authority expectations into program decision making.

Required Skills:

• Minimum BA/BS in Life Science with 5-8 years of pharmaceutical/biotech experience in analytical chemistry and/or regulatory affairs.
• Demonstrated expertise writing CMC content for US and global regulatory submissions, particularly for Biologic and Cell Therapy Products.
• Experience with ICH, CTD, and electronic submission guidelines, along with excellent project management and computer skills.

Work Environment:

• This job operates in a professional or remote office environment and requires standard office equipment.
• Must be able to remain stationary for prolonged periods, handle multiple priorities, and meet deadlines with excellent judgment and problem-solving skills.