1 Dec 2022
Full-Time Associate Director – CMC
Job Description
Serves as a key regulatory CMC interface with FDA and other Health Authorities and acts as regulatory CMC lead for various product sub-teams to develop, maintain and obtain alignment of global regulatory strategies in accordance with business plans. The incumbent is expected to exhibit leadership behaviors consistent with level and to act with a high degree of flexibility and prompt response in a fast-paced work environment. In addition, the role ensures compliance with global regulatory requirements and proactively anticipates and mitigates regulatory risks.
- Provides strategic and operational regulatory direction on projects including, but not limited to general CMC regulatory strategies, regulatory CMC requirements for clinical studies and marketing approval in domestic and international markets, and direct interactions with health authorities.
- Uses knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals
- Able to articulate regulatory CMC issues and support global development and commercialization of early and late state programs
- Oversees and/or leads the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met
- Reviews CMC sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
- Works independently on complex issues with some supervision from senior regulatory leadership. Integrates regulatory plans with various other functions including R&D, Quality, and Manufacturing to align operational plans and schedules in order to achieve the program objectives.
Minimum Requirements
Experience / Skills:
- Bachelor degree preferably in a scientific or technical field; advanced scientific-related degree preferred
- Seven (7) years drug/device development experience with five (5) years in regulatory activities
- Hands on experience with preparation of regulatory submissions associated with pharmaceutical products
- CMC experience (biologics) is a plus
- Experience in post approval activities desirable
- RAC certification desirableMaintains awareness of global regulatory environment and assesses impact of changes on business and product development programs.
Competencies:
- Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.
- Ability to establish and maintain collaborative relationships with key employees in Regulatory, R&D, Quality Assurance; Operations; Commercial and Legal, as well as positive interactions with senior management. Experience in working in and with interdisciplinary teams including partner organizations.
- Knowledge of regulatory affairs CMC; FDA & EU guidelines and regulations with an emphasis registration requirements; experience with Rest of World submission requirements. Knowledge of content and preparation of all regulatory CMC documents and experience in maintaining regulatory compliance within pharmaceutical industry.
- Has a proven ability to prioritize and meet project deadlines and demonstrates flexibility, creativity and timely responsiveness in a fast paced work environment. Highly developed organizational and project management skills to ensure quality dossiers.
- Detailed knowledge of content and preparation of CMC regulatory documents and experience in maintaining regulatory compliance within pharmaceutical industry. Developing and/or demonstrating competency in FDA & EU guidelines and regulations with an emphasis on CMC registration requirements. Experience with preparation of regulatory CMC submissions associated with pharmaceutical products
- Addresses issues and challenges rapidly and in a proactive and positive manner.
- Knowledge of EDMS systems, regulatory publishing, preparation of regulatory submissions and expertise with Microsoft Office programs
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