CMC Regulatory Sciences Specialist, Distribution Compliance

Rensselaer, NY, United States
Feb 23, 2019
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: 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 ensuring 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

• 0 to 2+ years of relevant experience working in the biopharmaceutical manufacturing or related industry preferred

Title level (Associate Specialist or Specialist) will be determined based on qualifications 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.