Associate Manager CMC Regulatory Sciences - Distribution Compliance

Location
Rensselaer, New York, US
Posted
Nov 14, 2018
Ref
14733BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . Provide expertise and leadership in regulatory aspects of distribution compliance within the CMC Regulatory Sciences Department . Essential Duties and Responsibilities include, but are not limited to, the following . Ensures drug supply distribution compliance beyond GMP compliance with all aspects of global regulatory filings to ensure stable supply positioning . Collaborates cross-functionally to support clinical and commercial regulatory release process and inventory review . Executes relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution . Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions / approvals . Keeps management and all stakeholders informed of assessments, overall strategy, and project status . Manages and develops team of direct reports . Knowledge and Skills . Proven ability to formulate a compelling vision and develop a strategy with key stakeholders to achieve that vision . Highly effective in an ambiguous environment and able to produce maximum results with little direction and guidance . Demonstrated history of building and maintaining positive relationships both internally and externally . Strong ability to communicate at all levels with clarity and precision . Open and receptive to change while looking for opportunities to continuously improve processes . Strong understanding of quality principles in a regulated manufacturing environment helpful . Education and Experience . Requires BS/BA in Chemistry, Biology or related field advanced degree preferred . 5+ years of experience working in the biopharmaceutical manufacturing or related industry including 3 years of experience working in regulatory or compliance related activities . Minimum 2 years of leadership and/or managerial experience required . Strong compliance background preferred . Experience in program management a plus Title level Associate Manager or Manager will be determined based on skills and experience relevant to the role . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law #LI-DR1.