Associate CMC Regulatory Sciences Specialist, Distribution Compliance

Location
Rensselaer, NY, United States
Posted
Sep 16, 2020
Ref
21463BR
Required Education
Bachelors Degree
Position Type
Full time
Summary: Performs activities in support of the regulatory aspects of distribution compliance within the CMC Regulatory Sciences Department.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Performs activities supporting 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.
• Participates in development and execution of procedures and systems for enhanced tracking of change controls and global regulatory submissions / approvals.
• Keeps management and other stakeholders informed of assessments and project status.
• Develops and maintains reporting tools to communicate regulatory distribution compliance status to the business.
• Identifies project or resource constraints and contributes to the development of alternate strategies.

Knowledge, skills, and abilities:
• Strong written, verbal and interpersonal communication skills and the ability to effectively interact cross-functionally
• Familiarity with pharmaceutical regulatory submissions and knowledge of FDA and international agency regulations
• Ability to organize and maintain accurate data or information
• Ability to handle multiple assignments and changing priorities
• Ability to learn and utilize computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines

Education and Experience:
• Requires BS/BA in Chemistry, Biology or related field with 0 to 2 years of relevant experience working in the biopharmaceutical manufacturing or related industry preferred.
• Or equivalent combination of education and experience.
• Title (Assoc. Specialist/Specialist) will be determined based on previous experience.

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.