Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
The Manager CMC Regulatory Affairs is responsible for interpreting the current, approved and planned clinical regulatory landscape by contributing to the management of the regulatory submission form process
Essential Duties and Responsibilities include, but are not limited to, the following:
Contributes to the management of the regulatory submission form process, which involves the review of submitted documentation to global health authorities to support the release of lots to clinical trials.
Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.
Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials. Ensure appropriate communication between IOPS and global development in a timely manner.
Participates in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
Lead meetings and presentation on more complex regulatory issues and participates in creating regulatory justifications.
Keeps management and all stakeholders informed of assessments, overall strategy, and project status.
Contribute to training programs, metrics, and invoice approvals.
May act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure the submissions appropriately support the release of IP.
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 experience working in regulatory or compliance related activities.
• Minimum 2 years of leadership and/or managerial experience required.
Knowledge and Skills:
Ability to build collaboration and teamwork across cross functional teams.
Working in an ambiguous environment and able to produce maximum results with minimum direction and guidance.
Demonstrated history of building and maintaining positive relationships both internally and externally.
Strong communication and negotiation skills
Open and receptive to change while continually looking for opportunities to improve processes.
Strong understanding of quality principles in a regulated manufacturing environment would be helpful.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
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