Regulatory Affairs Manager jobs in Massachusetts
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
- OneSource Regulatory
-
Boston, MA
FULL_TIME
-
Join the OSR Team to transform Regulatory Operations project submission management and the way you work.
About OneSource Regulatory
OneSource Regulatory™ helps companies implement the correct solutions, processes, standards, systems, templates, and best practices for effective Regulatory Operations. With the right Regulatory Operations group, our clients can achieve high quality document management, data management, and regulatory agency submissions.
Today we provide the following exemplary operations services:
- Regulatory Operations service provider to over 100 small to large sized companies
- Process Optimization
- System Implementations
- Document Management
- Submission Management
- Publishing
- Archiving
- RIM
- Submission Managers
- Publishers
- Fully Outsourced Regulatory Operations
Experience in pharmaceutical, biotechnology, medical device, nutritional supplements, animal health and cosmetic products
Collaborative professionals who file applications for new brands as well as maintain growth and legacy products
We hire the best, most experienced and collaborative experts in the industry and ensure that they have the latest resources and technology solutions.
- Work from anywhere
- Competitive salary & innovative incentive programs
What You’ll Do
Do you want the opportunity to work with a diverse group of pharmaceutical companies and provide publishing support for some of the most innovative products in the industry - from the comfort of your home?
OneSource Regulatory (OSR), is seeking qualified Regulatory Operations Submission Management professionals based in the US. You should be a collaborative team member who provides planning and execution of regulatory submissions (clinical trial applications, HA meeting packages, NDA/MAA) for several client products through effective interaction with submission teams, Regulatory Leads, and the OSR Regulatory Operations Director. You should have a strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.
The OneSource Regulatory team is comprised of the top experts in Regulatory Operations. OSR team members have an average of 15 years of industry experience in large, mid-size and small companies across every therapeutic area.
At OSR, you will be offered interesting and challenging work, and your position will come with a competitive salary, a flexible schedule and innovative incentive programs that reward your contributions and innovations. You will have the opportunity for personal and professional development through internal coaching and mentoring, in addition to the opportunity to attend key external events.
Learn more about OSR by visiting our website: www.OneSourceRegulatory.com
Questions? Email us at info@OneSourceRegulatory.com
Interested in joining the OSR Team?
Provide your information through the BambooHR form below.
- 1 Month Ago
- OneSource Regulatory
-
Boston, MA
FULL_TIME
- Join the OSR Team to transform Regulatory project management and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companies implement the correct solutions, processes, standard...
- 1 Month Ago
- Collabera
-
Mansfield, MA
FULL_TIME
- Company DescriptionEstablished in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar I...
- 1 Month Ago
- Pramand LLC
-
Bedford, MA
FULL_TIME
- About Us: Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering...
- 21 Days Ago
- Viridian Therapeutics, Inc
-
Waltham, MA
FULL_TIME
- Description At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to...
- 5 Days Ago
- Fresenius Kabi USA
-
North Andover, MA
FULL_TIME
- Job Summary The Manager, Regulatory Affairs is responsible for defining and implementing regulatory strategies and submissions in support of new and existing market authorizations. Participate on cros...
- 13 Days Ago
Regulatory Affairs Manager jobs at Popular Companies
- 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
- Akston Biosciences Corporation
-
Beverly, MA
- Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
- 4/25/2024 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
- Capstone Development Services Co, LLC
-
Rosemont, IL
- Company Capstone, a fast-growing, private equity-owned pharmaceutical company; develops complex generic products, intern...
- 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