Regulatory Affairs Manager jobs in Lynn, 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)

O
Regulatory Operations Submissions Manager - OneSource Regulatory
  • 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. 

  • 23 Days Ago

O
Regulatory Operations Project Manager - OneSource Regulatory
  • 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...
  • 23 Days Ago

I
SENIOR/MANAGER, REGULATORY AFFAIRS
  • ImmunoGen, Inc.
  • Waltham, MA FULL_TIME
  • Overview Work Location: US Headquarters, Waltham, MA (3 Days / Week in Office) About the Role Cancer doesn’t care how it disrupts the course of lives. We do. Since our founding, we have pursued one go...
  • 23 Days Ago

X
Senior Manager, Regulatory Affairs
  • xenon
  • Boston, MA FULL_TIME
  • Who We Are: At Xenon Pharmaceuticals (NASDAQ:XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, ...
  • Just Posted

L
Regulatory Affairs Manager
  • Leap Energy
  • Boston, MA FULL_TIME
  • About UsLeap’s mission is to combat climate change by enabling a reliable electric grid that runs on clean energy. The electric grid is transforming from dirty (but predictable) fossil fuels to clean ...
  • 9 Days Ago

I
Manager Regulatory Affairs-CMC
  • Integrated Resources INC
  • Lexington, MA FULL_TIME
  • Company DescriptionIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent ...
  • 11 Days Ago

Filters

Clear All

Filter Jobs By Location
  • Filter Jobs by companies
  • More

0 Regulatory Affairs Manager jobs found in Lynn, MA area

P
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...
  • 3/28/2024 12:00:00 AM

B
Regulatory Manager
  • BostonGene
  • Waltham, MA
  • Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our I...
  • 3/28/2024 12:00:00 AM

B
Program Manager - Regulatory and Accreditation Programs
  • Beth Israel Lahey Health
  • Boston, MA
  • When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. Job Typ...
  • 3/28/2024 12:00:00 AM

B
Developmental Specialist 3 - Department 782
  • Bridgewell
  • Danvers, MA
  • Bridgewell strengthens communities by providing an unmatched range of social and human services that empower people with...
  • 3/28/2024 12:00:00 AM

C
Regulatory Affairs Sr Manager (Medical Device)
  • Connexion Systems & Engineering, Inc.
  • Westford, MA
  • Job Description Job Description Job Title: Sr. Manager Regulatory Affairs Salary: $180-$195K (15% bonus) Location: Westf...
  • 3/26/2024 12:00:00 AM

A
Regulatory Affairs Associate
  • Ajinomoto Health & Nutrition North America, Inc.
  • Ayer, MA
  • Overview: The Regulatory Affairs Associate is a key contributor to the regulatory affairs team at Ajinomoto Cambrooke, I...
  • 3/25/2024 12:00:00 AM

S
Corporate Accounting, Assistant Vice President
  • State Street Corporation
  • Boston, MA
  • With over $41 trillion in assets under custody and administration, and over $4 trillion in assets under management as of...
  • 3/25/2024 12:00:00 AM

S
Front Desk Specialist
  • Spire Orthopedic Partners
  • Peabody, MA
  • Job Description Job Description Title: Front Desk Specialist Reports to: Site Supervisor Location – onsite Hours: Monday...
  • 3/25/2024 12:00:00 AM

Lynn is the 9th largest municipality in Massachusetts and the largest city in Essex County. Situated on the Atlantic Ocean, 3.7 miles (6.0 km) north of the Boston city line at Suffolk Downs, Lynn is part of Greater Boston's urban inner core. Settled by Europeans in 1629, Lynn is the 5th oldest colonial settlement in the Commonwealth. An early industrial center, Lynn was long colloquially referred to as the "City of Sin", owing to its historical reputation for crime and vice. Today, however, the city is known for its contemporary public art, international population, historic architecture, dow...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$154,795 to $218,336
Lynn, Massachusetts area prices
were up 2.5% 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