Associate Manager Cmc Regulatory Sciences - Troy, United States - Regeneron Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc.

Verified Company

Troy, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

In this role, a typical day might include the following:

Preparing and reviewing global CMC documents and sections for a variety of commercial biopharmaceutical regulatory submissions, verifying that all submissions are complete, accurate and meet relevant requirements.

Handling and coordinating the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from regulatory agencies, in accordance with submission timelines, keeping all team members, including third-party partners, advised of progress.

Collaborating and developing excellent relationships with functional area and cross functional teams, contract manufacturing organizations and global Regulatory partners.

Reviewing relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.

Proactively identifying issues and contributing to the development of appropriate strategies to mitigate risk.

Assisting in preparation for meetings with global regulatory authorities.

Contributing to developing CMC regulatory strategy.

This role may be for you if you have:
Excellent written and verbal communication skills.

An ability to work independently, prioritize, coordinate, and complete multiple projects within deadlines while maintaining a level of attention to detail.

Knowledge of and experience with global CMC registration and life cycle management regulations and guidelines (e.g., FDA regulations and ICH guidelines) as well as an understanding of cGMPs (Current Good Manufacturing Practices).

Strong skills in planning, critical thinking, and problem-solving.

To be considered for the CMC Regulatory Sciences Associate Manager role, you must have a BA/BS degree, preferably in a scientific related field, with 8+ years of experience or an MS degree with 7+ years of experience.

Level is determined based on qualifications relevant to the role.

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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Range (annually) $76, $124,300.00