WorcesterRecruiter Since 2001
the smart solution for Worcester jobs

Regulatory Manager - Global Regulatory Affairs

Company: Tech Observer
Location: Worcester
Posted on: December 4, 2019

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, Worcester , Regulatory Manager - Global Regulatory Affairs, Executive , Worcester, Massachusetts

Click here to apply!

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

I'm looking for
in category

Other Executive Jobs

Product Security Program Manager - Process Optimization & Education
Description: Product Security Program Manager ------ Process Optimization EducationLocation: --Hopkinton, MA Round Rock, TX or Remote - USDell provides the technology that transforms the way we all work and live. (more...)
Company: Dell
Location: Brockton
Posted on: 12/14/2019

Chief Financial Officer (CFO) Inpatient Mental Health - Haverhill Behavioral Hospital
Description: Job Snapshot Employee Type: Full-Time Location: Haverhill, MA Job Type: Accounting / Finance Date Posted: 11/18/2019 Job Description Overview Looking to make a difference Haverhill Behavioral Health (more...)
Company: Acadia- Rolling Hills Hospital
Location: Haverhill
Posted on: 12/14/2019

JR. Project Manager
Description: Provide project-related support to the Project Management Office and to the Project Manager on assigned projects.Edit and maintain project and resource plans.Assist in coordinating
Company: Albano Systems Inc
Location: Springfield
Posted on: 12/14/2019

Tax Manager
Description: RESPONSIBILITIES:Kforce has a client in search of a Tax Manager in Providence, Rhode Island RI . br br Duties Include: br br br ul br li Serve as an advisor
Company: Kforce
Location: Providence
Posted on: 12/14/2019

Director of Global Evidence & Value Development, Strategy Lead, Neurology (HEOR)
Description: A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance (more...)
Company: EMD Serono
Location: Billerica
Posted on: 12/14/2019

Clinical Director
Description: Job Description Overview Our Passion: We are improving the lives we touch. We need passionate, talented people working together who share our desire to provide the best quality care to our patients and (more...)
Company: Acadia Healthcare
Location: New Bedford
Posted on: 12/14/2019

Sales Manager
Description: Job Description:Seeking Financial Sales Services Professionals / Sales Management Financial Sales Representatives help clients identify and achieve their financial goals. We offer a comprehensive (more...)
Company: New York Life
Location: Worcester
Posted on: 12/14/2019

Quality Disposition,Manager
Description: By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takedas Privacy Notice, Privacy Policy and Terms of Use. Job Description (more...)
Company: Millennium Pharmaceuticals, Inc.
Location: Lexington
Posted on: 12/14/2019

Director of Spiritual Care
Description: Who we are:Rooted in the heritage of the Sisters of Notre Dame de Namur, Notre Dame Health Care NDHC is committed to the physical, spiritual, and emotional care of our residents and patients. As one (more...)
Company: Notre Dame Health Care Center, Inc.
Location: Worcester
Posted on: 12/14/2019

Director Perioperative Services St. Vincent Hospital $20K Sign on Bonus
Description: SUMMARY: This role provides leadership and support to thesenior executive position COO responsible for all nursing and otherdesignated patient care functions x2F services within the hospital organization.The (more...)
Company: Tenet Health
Location: Worcester
Posted on: 12/14/2019

Log In or Create An Account

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

Worcester RSS job feeds