Regulatory Affairs Manager jobs in New York
Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Manager jobs
- Regeneron Pharmaceuticals Inc.
-
Rensselaer, NY
FULL_TIME
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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.
$104,300.00 - $170,100.00Does 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.Salary Range (annually)
- 2 Days Ago
- Katalyst Healthcares & Life Sciences
-
Sleepy Hollow, NY
FULL_TIME
- Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accurac...
- 2 Days Ago
- Elliquence
-
Baldwin, NY
FULL_TIME
- elliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with ...
- 8 Days Ago
- amika
-
Brooklyn, NY
FULL_TIME
- hi there, we’re amika. a friend to hair, hairstylists, her, him, them, you. amika means friend in the language esperanto and is a symbol of our belief in the power of community the beauty of diversity...
- 14 Days Ago
- Zentalis
-
Remote, NY
FULL_TIME
- JOB SUMMARY: Responsible for drafting cover letters for submissions and for being the regulatory point of contact internally for DSURs and IBs and for other documents as needed. Supports the implement...
- 1 Month Ago
- Sol de Janeiro
-
New York, NY
FULL_TIME
- This role will support the Global Regulatory Affairs department to propel the hypergrowth and rapid global expansion of the brand. Someone who loves the complexity and detail orientation of global reg...
- 28 Days Ago
Regulatory Affairs Manager jobs at Popular Companies
- Catalyst Life Sciences
-
Chicago, IL
- Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
- 4/26/2024 12:00:00 AM
- Pharvaris
-
Boston, MA
- Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases...
- 4/26/2024 12:00:00 AM
- Kenvue
-
Skillman, NJ
- Kenvue is currently recruiting for: Regulatory Affairs Manager This position reports to Director, Regulatory Affairsand ...
- 4/26/2024 12:00:00 AM
- Kenvue Inc.
-
Skillman, NJ
- Kenvue is currently recruiting for: Regulatory Affairs Manager This position reports to Director, Regulatory Affairs and...
- 4/26/2024 12:00:00 AM
- Ferris Mfg. Corp.
-
Fort Worth, TX
- Ferris Mfg. Corp., a successful and long-established Medical Device Manufacturer, is seeking a responsible, self-motivat...
- 4/26/2024 12:00:00 AM
- Mindlance
-
Chicago, IL
- Job Title: Regulatory Affairs Manager III Location: REMOTE Duration: 06 months with possible extension SUMMARY The Regul...
- 4/26/2024 12:00:00 AM
- Ferris Mfg. Corp.
-
Fort Worth, TX
- Ferris Mfg. Corp., a successful and long-established Medical Device Manufacturer, is seeking a responsible, self-motivat...
- 4/24/2024 12:00:00 AM
- Custom Search, Inc.
-
Minnetonka, MN
- Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance w...
- 4/22/2024 12:00:00 AM