Assoc. Dir. of CMC
BASIC FUNCTION:
The essential job function is to provide regulatory guidance and anticipated US and international CMC and manufacturing regulatory requirements to CMC and project teams. Contribute to the creation of global Regulatory Affairs strategy for development projects by providing input on CMC and manufacturing issues and strategies.
Direct staff in providing required Regulatory support on manufacturing / CMC issues, and be responsible for planning and coordinating regulatory submissions necessary to support product development and registration .
MAJOR RESPONSIBILITIES:
· Oversee, manage develop and provide global leadership to Manufacturing and CMC regulatory staff directing teams and committees in relevant areas of regulatory affairs creating, directing and executing global regulatory development strategies and plans and manage timelines to achieve the stated goals.
· Provide directional guidance to the business on how to prepare manufacturing and CMC aspects of product development for approval, globally and keeps abreast of evolving global regulatory requirements establishing global departmental priorities for projects based on input, planning and coordination with other key functional leaders.
· Ensure that all strategic and tactical activities are conducted in compliance with relevant laws working closely with clinical and manufacturing departments and across project teams to, regulations, and guidance. Ensure clear communication of project activities and progress in a timely manner.
· Direct staff in the planning and preparation and submission of required documents to regulatory agencies. Ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements.
· Develop and implement innovative regulatory strategies for manufacturing and CMC-related projects overseeing the planning and coordination of productive and effective regulatory submissions and regulatory agency meetings
· Effect timely and appropriate regulatory management of manufacturing / CMC changes to products. Supervise preparation of regulatory documentation to update regulatory applications.
· Maintain comprehensive and current expertise in FDA, ICH, European guidelines and regulations concerning CMC requirements and policies.
· Work with QA, QC and manufacturing to assure that all regulatory requirements are met.
· Ensure that CMC regulations are communicated through company policies and procedures and advise on the creation and revision of SOPs governing CMC activities.
· Review and approve all changes to manufacturing processes to ensure compliance with global regulatory guidelines.
· Advise project teams, Operations, Quality, and R&D on appropriate specifications for raw materials, manufacturing components, process intermediates, and finished products to assure adequate regulatory controls for the life cycle of all regulated products.
· Mentor and/or manage other Regulatory staff and other junior level or administrative
Regulatory staff if applicable leading and developing personnel to promote compliance with all laws, regulations, or guidance.
· Negotiate and make internal and external agreements on behalf of the department.
· Serve as a key global contact to the Health Authorities and facilitates communication between the Health Authorities and the project team for Manufacturing and CMC-related matters building and maintaining excellent relationships with regulatory authorities..
· Follow other job-related duties and performs other job-related duties as assigned.
KNOWLEDGE AND EXPERIENCE:
AMOUNT AND TYPE OF EDUCATION AND TRAINING
· BS in Biological Sciences, Chemistry or related science fields with a minimum of 10 years of pharmaceutical industry experience including a minimum of 7 years of Regulatory Affairs experience. An advanced degree in any of the aforementioned fields is preferred although not required.
· Demonstrates expert knowledge of regulations, guidelines and precedents related to global regulatory affairs, manufacturing and CMC and product development
· Management and demonstrable leadership skills
· Strong negotiation, communication and interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
GENERAL REQUIREMENTS:
1. He/she must be a dedicated self starter with a high energy level and able to achieve results.
2. He/she should have strong communication and leadership skills-the ability to influence and work
successfully with colleagues, customers, and corporate partners.
3. The candidate should have experience in handling multiple projects at a time.
4. Some travel required.
