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 CMC regulatory strategies for the development of protein therapies, lead CMC regulatory activities for assigned projects in line with US or ICH 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
• 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
• B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
• 8 - 10 years of drug development experience including significant strategic experience in CMC regulatory affairs with a strong biologics background.
• Demonstrated leadership in regulatory strategy and experience in regulatory interactions
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.