CMC Regulatory Affairs Manager

Job description

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) Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.