CMC Regulatory Affairs Manager

This position is responsible for preparation of CMC submissions for Biologics products. This position will also assist the Regulatory CMC team with special projects as assigned.

• Responsible for implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs.
• Responsible for coordinating all aspects of regulatory CMC submissions relevant to assigned projects or programs
• Identify and assess regulatory risks associated with product development for assigned programs. Assist in defining strategies to mitigate risks
• Guide the organization and preparation of clear and effective submissions.
• Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards
• Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on specific projects
• Assess compliance of CMC document with the current Guidelines and Regulations
• Assess regulatory impact of proposed CMC changes to licenses or clinical trial applications
• BA/BS/University degree required, Life/Health Sciences preferred.
• A minimum of 7 years in the Pharmaceutical Industry, and a minimum 5 years regulatory CMC experience (Biologics)
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Demonstrate excellent communication skills.
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
• Demonstrate effective cross-cultural awareness and capabilities.
• Some direct experience in interfacing with relevant regulatory authorities.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
• Good knowledge and understanding of applicable regulations.
• Experience in interpretation of regulations, guidelines, policy statements, etc.
• Computer literate.
• Sensitivity for a multicultural/multinational environment. Kind Regards, Sabanaaz Shaikh Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)