Manager, CMC Regulatory Sciences - Distribution Compliance

Location
Troy, New York, United States of America
Posted
Jun 13, 2021
Ref
24763BR
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Manager CMC Regulatory Sciences - Distribution Compliance with a first shift, Monday-Friday, 8:30am-4:30pm schedule. Our Managers in CMC Regulatory Sciences - Distribution Compliance are ensuring that our products reach our patients while fulfilling regulatory compliance obligations.

As a Manager CMC Regulatory Sciences - Distribution Compliance, a typical day might include 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.

This role might be for you if:
• You have a proven ability to formulate a compelling vision and develop a strategy with key stakeholders to achieve that vision.
• You are highly effective in an ambiguous environment and able to produce maximum results with little direction and guidance.
• You have demonstrated a history of building and maintaining positive relationships both internally and externally.
• You have a strong ability to communicate at all levels with clarity and precision.
• You are open and receptive to change while looking for opportunities to continuously improve processes.
• You have a strong understanding of quality principles in a regulated manufacturing environment

To be considered for the position you must have a BS/BA in Chemistry, Biology or related field (advanced degree preferred) and 7+ years of experience, working in the biopharmaceutical manufacturing or related industry. This experience should include 3 years working in regulatory or compliance related activities, and a minimum 2 years of supervisory experience is required. Strong compliance / quality background preferred, experience in program management is a plus.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.