SanofiCambridge, 6 mi from Waltham (MA)
About the Role
The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. As the RC RA representative, work...
SanofiCambridge, 6 mi from Waltham (MA)
Global Regulatory Affairs Lead (GRL)
Mission statements
• The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies...
Editas MedicineCambridge, 6 mi from Waltham (MA)
to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary
As the Senior Manager of Regulatory Affairs, you will play...
Accede Solutions IncLexington (MA), 5 mi from Waltham (MA)
Hybrid Role
The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across...
The Fountain Group LLCCambridge, 6 mi from Waltham (MA)
The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows:
Job Description:
Pay: 75.00...
Abacus Technology CorporationHanscom Air Force Base
Knowledge of support activities that assist the program manager in assessing what programs are within schedule and cost baselines, be able to recommend viable solutions to problems, and the pursuit of alternative courses of action. Abacus Technology is seeking a Program Manager to provide acquisitio...
AKIMABoston
The Program Manager leads project workstreams for a complex Air Force Enterprise IT modernization effort that delivers Software-Defined Wide Area Network (SD-WAN) and Secure Access Service Edge (SASE) solutions. Act as the single point of contact for all SD-WAN and SASE Original Manufacturers (OEMs)...
Booz Allen HamiltonLexington
Cloud Application Migration Project Manager. As an Application Migration Program Manager, you know how to take advantage of cloud. Experience with project management tools, including Jira, Trello, or Asana. Knowledge of project management methodologies, including Agile, Waterfall, and DevOps.
...
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Manager, Regulatory Affairs
Waltham (MA) | www.resume-library.com |
Job Description
The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.
This role is responsible for the supporting regulatory submissions such as: investigational new drug applications (INDs), clinical trial applications (CTAs) and components of marketing applications as well as post-approval submissions and life-cycle maintenance activities.
Key Responsibilities:
Provide input to global regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices
Previous experience with compilation and filing of INDs, IND amendments, NDA, NDA supplements and CTAs.
Represent the regulatory affairs function on project teams to provide regulatory support and advice
Interact with corporate partners and contracted vendors regarding various regulatory matters
Provide support for regulatory interactions, including meetings and teleconferences with global health authorities
Show good judgment to determine when to escalate problems to his/her superior
Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function
The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.
This role is responsible for the supporting regulatory submissions such as: investigational new drug applications (INDs), clinical trial applications (CTAs) and components of marketing applications as well as post-approval submissions and life-cycle maintenance activities.
Key Responsibilities:
Provide input to global regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices
Previous experience with compilation and filing of INDs, IND amendments, NDA, NDA supplements and CTAs.
Represent the regulatory affairs function on project teams to provide regulatory support and advice
Interact with corporate partners and contracted vendors regarding various regulatory matters
Provide support for regulatory interactions, including meetings and teleconferences with global health authorities
Show good judgment to determine when to escalate problems to his/her superior
Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function
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