Regulatory Affairs Manager jobs in Lawrence, MA

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)

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Manager, Regulatory Affairs
  • 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 cross-functional project teams and act as global regulatory advisor. This position will be supporting Infusion Systems within Regulatory Affairs. Responsibilities Represent Regulatory on assigned product/project teams; establish and implement regulatory strategies that align with project objectives Develop and execute regulatory plans for complex projects including new product development, new registrations, product modifications, maintenance of existing licenses, and ongoing compliance activities Strategize and prepare local and global regulatory submissions for assigned projects Monitor applicable regulatory requirements for products within area of responsibility and inform product/project teams of upcoming changes in applicable regulations and guidance documents Perform gap analyses and propose solutions to ensure compliance with local and global regulations as well as internal and external standards Establish and maintain appropriate communication within Regulatory and across other functions primarily at project level Develop and document sound regulatory decisions and justifications Interact with regulatory agencies for assigned projects/submissions as directed by supervisor; respond to (or help with) regulatory agency questions within defined timelines Review and approve product labeling and advertising/promotional materials for compliance with applicable regulatory requirements Review technical documentation for suitability to support regulatory applications Act as regulatory project manager on assigned projects. Collaborate with subject matter experts and drive project team to achieve established regulatory submission timelines Mentor and train other regulatory staff Requirements Bachelor's degree with minimum of 6 years’ experience in a function such as regulatory, quality, or clinical in the life sciences industry, OR high school diploma with minimum of 8 years’ experience in medical device or pharmaceutical regulatory affairs Experience in authoring infusion system applications to FDA is highly preferred (e.g., pre-subs, 510(k)s, IDEs) Sound regulatory and scientific knowledge Experience and proven effective collaboration in a multicultural environment Strong oral and written communication and presentation skills Demonstrated interpersonal skills including strong negotiation skills Ability to manage complex projects and timelines in a matrix team environment Ability to independently identify compliance risks and escalate when necessary Ability to lead and coach others Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi (www.CaringForLife.us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 40,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address – messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using “Fresenius-kaabi.com” which of course includes an extra “a” in “Kabi.” Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your driver’s license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at HRLakeZurich@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.
  • 5 Days Ago

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Regulatory Affairs III Associate
  • RQMIS
  • Amesbury, MA FULL_TIME
  • Our Mission RQMIS’ mission is to bring about safe and effective medical devices and biotechnology products by assisting companies in navigating the regulatory process and addressing governmental requi...
  • 5 Days Ago

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Director, Regulatory & Quality Affairs
  • MDC Associates
  • Beverly, MA FULL_TIME
  • The Director of Regulatory & Quality Affairs will be a critical team member supporting MDC's regulatory and quality affairs business and support client RA/QA strategy and regulatory submissions. The p...
  • 1 Month Ago

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Store Manager
  • Garage clothing-Store manager-Mall of Rockingham,...
  • Salem, NH FULL_TIME
  • Seize the opportunity to join a global fashion retailer with two brands at the heart of its success, Garage and Dynamite, selected as one of Montreal's Top Employers 2020 and as one of Canada’s Top em...
  • 16 Days Ago

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Assistant Store Manager
  • Garage Clothing-Assistant Manager-Rockingham Mall,...
  • Salem, NH FULL_TIME
  • Seize the opportunity to join a global fashion retailer with two brands at the heart of its success, Garage and Dynamite, selected as one of Montreal's Top Employers 2020 and as one of Canada’s Top em...
  • 10 Days Ago

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Regulatory Analyst
  • CORESTAFF Services
  • Andover, MA FULL_TIME,CONTRACTOR
  • JOB DESCRIPTION:The Platforms and Regulatory Compliance group offers best-in-class technology and incorporate industry best practices to manage risk, comply with regulations and provide assistance to ...
  • 2 Days Ago

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0 Regulatory Affairs Manager jobs found in Lawrence, MA area

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Regulatory Affairs Manager
  • Pragmatic
  • Bedford, MA
  • About Our Client: Our client revolutionizes patient care with cutting-edge hydrogel-based medical devices. Their commitm...
  • 4/18/2024 12:00:00 AM

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Regulatory Affairs Manager (Biotech)
  • HireMinds
  • Waltham, MA
  • Manager, Regulatory Affairs Waltham, MA *this job requires 3 days per week on-site in Waltham, MA Our client is a biopha...
  • 4/18/2024 12:00:00 AM

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Manager/Sr. Manager, Regulatory Affairs
  • Planet Pharma
  • Waltham, MA
  • Job Description: The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-fun...
  • 4/18/2024 12:00:00 AM

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Regulatory Affairs Manager (Biotech)
  • Hireminds
  • Waltham, MA
  • Manager, Regulatory Affairs Waltham, MA *this job requires 3 days per week on-site in Waltham, MA Our client is a biopha...
  • 4/17/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Pragmatic
  • Bedford, MA
  • About Our Client: Our client revolutionizes patient care with cutting-edge hydrogel-based medical devices. Their commitm...
  • 4/16/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Akston Biosciences Corporation
  • Beverly, MA
  • Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
  • 4/16/2024 12:00:00 AM

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Manager/Sr. Manager, Regulatory Affairs
  • Planet Pharma
  • Waltham, MA
  • Job Description: The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-fun...
  • 4/16/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Akston Biosciences Corporation
  • Beverly, MA
  • Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
  • 4/15/2024 12:00:00 AM

According to the United States Census Bureau, the city has a total area of 7.4 square miles (19 km2), of which 7.0 square miles (18 km2) is land and 0.4 square miles (1.0 km2) (6.07%) is water. Lawrence is on both sides of the Merrimack River, approximately 26 miles (42 km) upstream from the Atlantic Ocean. On the north side of the river, it is surrounded by Methuen. On the south side of the river, the town is bordered by North Andover to the east, and Andover to the south and southwest. Lawrence is approximately 30 miles (48 km) north-northwest of Boston and 27 miles (43 km) southeast of Manc...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$147,127 to $207,531
Lawrence, Massachusetts area prices
were up 1.6% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020