LowellRecruiter Since 2001
the smart solution for Lowell jobs

Regulatory Manager - Global Regulatory Affairs

Company: Tech Observer
Location: Lowell
Posted on: January 15, 2021

Job Description:

This is a contract opportunity for Senior Regulatory Manager - Global Regulatory Affairs located in Cambridge, MA. Summary: Will be responsible for being US regulatory lead on early development programs and providing US regulatory support for both development and marketed products. In this capacity, the Senior Manager will be responsible for supporting development programs and marketed products working with the Global Regulatory team and (regions, Regulatory CMC, Regulatory Operations, EU authorized representatives, labeling). Support the preparation of regulatory documentation and submission activities to meet business and agency milestones. Lead the development and submission of initial INDs. Create submission plans and manage timelines in MS Project, and document workflow from draft through finalization for US submissions. Prepares routine submissions in compliance with department and regulatory requirements and guidelines. Assists with larger or more complex submissions. Identify risks to timeline and assists the North American (NA) Regulatory lead Work with Regulatory Operations to identify resource requirements and strategies to address overlapping resource demands and rate limiting factors Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed Ensure regulatory plans are monitored, progress/variance communicated on assigned programs Collaborate within regulatory and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications in the US. Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, and pediatric investigation plans Participate in regulatory research activities, as needed. Skills: Minimum 4+ years of regulatory experience in a biotech/pharma company Excellent project management and writing skills, as well as a good understanding of the underlying science Experience with preparation of initial INDs, DSURs and meeting briefing documents. Experience with BLA, NDA, or MAA a plus. Understanding of the development of drugs and/or innovative biologics products. Experience in orphan drugs a plus A working understanding of regulations and guidelines related to drug development and registration is required. Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view Independently motivated, detail oriented and good problem solving ability Demonstrated ability to handle multiple projects is required. Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities Excellent communication skills and ability to influence across multiple functions.

Keywords: Tech Observer, Lowell , Regulatory Manager - Global Regulatory Affairs, Executive , Lowell, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Domino's General Manager in Training - Beverly - Earn btw $15 - $18 per hour FIRST YEAR (3782)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: South Hamilton
Posted on: 01/28/2021

Domino's General Manager in Training - Swampscott - Earn btw $15 - $18 per hour FIRST YEAR (9805)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: Marblehead
Posted on: 01/28/2021

Produce Manager
Description: Produce Manager FULL-TIME 15.50/hr The Produce Manager is responsible for the produce department and its staff. You will be responsible for ordering, receiving, merchandising, and maintaining correct (more...)
Company: Restaurant Depot
Location: Needham
Posted on: 01/28/2021


Event/Program Specialist
Description: Adecco is currently assisting a local client in their search to fill an Event/Program Specialist job in Tewksbury, MA. This is a contract opportunity. As an Event/Program Specialist you will be responsible (more...)
Company:
Location: Tewksbury
Posted on: 01/28/2021

Domino's General Manager in Training - Swampscott - Earn btw $15 - $18 per hour FIRST YEAR (9805)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: Swampscott
Posted on: 01/28/2021

Domino's General Manager in Training - Fenway - Earn btw $15 - $18 per hour FIRST YEAR (3741)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: North Waltham
Posted on: 01/28/2021

Domino's General Manager in Training - Georgetown - Earn btw $15 - $18 per hour FIRST YEAR (9807)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: Boxford
Posted on: 01/28/2021

Branch Manager
Description: External Title :Branch Manager Brand :Coldwell Banker Real Estate LLC About us : Realogy Holdings Corp. NYSE: RLGY is the leading and most integrated provider of U.S. residential real estate services, (more...)
Company: Realogy Holdings Corp
Location: Marblehead
Posted on: 01/28/2021

Domino's General Manager in Training - Beverly - Earn btw $15 - $18 per hour FIRST YEAR (3782)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: Nahant
Posted on: 01/28/2021

Quality Investigations Specialist - Pharma Industry
Description: Industry leading global pharmaceutical company is seeking a Quality Investigations Specialist to work in Woburn, MA. br br This a six 6 month temporary contract role, with the
Company:
Location: Woburn
Posted on: 01/28/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Lowell RSS job feeds