The Associate Director of CMC Regulatory Affairs will serve as the global product leader for CMC regulatory strategy of one or more biological and/or small molecule products. This will include formulating and implementing global CMC regulatory strategies for the development of protein therapies, lead CMC regulatory activities for assigned projects in line with global requirements.
Primary role includes:
- Serve as a liaison between the regulatory authorities and the company on CMC issues
- Provide CMC RA leadership within RA and on cross-functional CMC teams
- Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations
Describe the essential job duties. After each, provide an estimate of the percent of time typically devoted to each responsibility (use increments of 5%, all time spent should total to 100% of time allocation). To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.
- Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls (10%)
- Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities, for commercial and/or development programs. (50%)
- Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)
- Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)
- Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)
Education & Experience Requirements
Include educational requirements or equivalency, requiredyears and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred.
- B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
- At least 7years of drug development/pharmaceutical industry experience (or equivalent) including significant strategic experience (5+ years) in CMC regulatory affairs (or equivalent) with a small molecule and/or biologics background.
- Demonstrated leadership in regulatory strategy and experience in regulatory interactions
Key Skills and Competencies
Describe critical skills needed to successfully perform job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent interpersonal, communication, analytical and managerial skills.
- Demonstrated experience with global development, registration and post-approval submissions
- Ability to work successfully with cross-functional teams and influence appropriate plans and actions.
- Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
- Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
- Ability to work independently, take initiative and complete tasks to deadlines.
Other Job Components
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the incumbent’s authority to make as well as those decisions that must be referred to a higher level.
Internal and External Contacts
List contacts this job advises, consults and coordinates with on a regular basis. Describe to whom this job is accountable. Indicate each Contact Category (Internal, Vendor, Customer, or Other) and provide examples.