Average salary: $148,333 /yearly
More stats ...Senior Director, Regulatory Affairs
Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility...
Suggested
Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements...
Suggested
...studies, including vimseltinib and DCC-3116.
See here for more details on our portfolio.
Job Description
The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of...
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Temporary work
Summer work
Summer holiday
Flexible hours
...Job Description
Position Summary:
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication...
Suggested
...IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline candidates.
Description (Remote Role)
As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency...
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Remote job
Holiday work
Full time
Flexible hours
...?and?Facebook.
Role Summary:
This role is accountable for managing the submission activities and supporting development of Regulatory Operations practices. The Associate Director of Regulatory Operations is responsible for the assembly, publishing, and submission...
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Relief
Local area
Remote job
Relocation
The Public Affairs & Communications Associate will be passionate about telling the Massachusetts Life Sciences Center's (MLSC) story and promoting our mission of supporting the growth and development of the life sciences in Massachusetts.
In particular, this individual...
Suggested
Remote job
...Executive Director, Medical Affairs
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
2015
Employees
51-200
Categories
Pharmaceuticals
Medicine
Manufacturing
Chemical Products...
Suggested
...for non-promotional and promotional materials to comply with regulatory requirements worldwide throughout the product life cycle. The... ...activities. The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development...
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Local area
Worldwide
...*Learn more about thisposition at National Grid.**
**Job ID** 29550 **Location** Waltham, Massachusetts **Organization** Legal, Regulatory and Compliance **Department** Regulatory Strategy NY As one of the largest energy companies in the Northeast, National Grid plays...
Suggested
Work experience placement
Flexible hours
...About us
National Grid is hiring a Senior Analyst for the Policy & Regulatory Strategy team in Waltham, MA.
Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy...
Suggested
Work experience placement
Remote job
Flexible hours
...Job Description
Job Description Position Summary:
The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects...
Suggested
Work experience placement
Local area
...travel to Sobi sites for business-critical meetings/events. Candidates on the US East coast prefered.
The Senior Director Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Compliance, Operations, Labeling and AdPromo (COLAP) and...
Suggested
Temporary work
Summer work
Remote job
...report to the VP of QA/RA and work with a cross functional team to assure all aspects of a new product lines compliance with all Regulatory, Clinical and QA technical, clinical and marketing requirements.
Key Responsibilities and Activities
The experienced and...
Suggested
Work experience placement
...through active social networks & employee resource groups.
Job Purpose
The Senior Analyst, MA AMI Customer, Community, and Regulatory Engagement is a key member of the MA Advanced Metering Infrastructure (AMI) program team that develops and manages our customer engagement...
Suggested
Flexible hours
...Job Purpose
To lead assigned policy and regulatory initiatives, engaging with cross-functional teams and senior leadership on complex and challenging issues. This role is responsible for directing and conducting financial analysis, evaluating the business case for...
Remote job
Offshore
...Brandeis University is delighted to announce a career opportunity an Assistant Director of Graduate Affairs. If you are looking for an opportunity to work at a beautiful suburban campus with lots of perks including free parking, look no further. At Brandeis, we offer...
Work experience placement
Night shift
...and concise communication of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders. This... ...Manager Title
Vice President, Head of Global Regulatory Affairs
Travel Percent
Less than 10%
Functions
CEO/President...
...and interpret clinical trial data, author clinical study and regulatory communications.
Key Responsibilities Include:
Provide sponsor... ...Contribute to clinical advisory boards and support Medical Affairs as needed.
Education, Registration & Certification:
~3+...
Local area
...selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions...
Temporary work
Work experience placement
Summer work
Summer holiday
Remote job
Flexible hours
...required to complete study-specific tasks on time and with high quality
Work collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables.
Provide guidance on clinical data management to CDM staff, study teams...
Temporary work
Summer work
Summer holiday
Flexible hours
...and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations and advises on impact of such regulations on the company; may...
Remote job
Contract work
Local area
Night shift
...Job Title
Principal Regulatory Affairs Specialist
Job Description
Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based)
The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory...
Remote job
Relocation
Work visa
...have you in front of a live recruiter.
The Opportunity
Description
We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Works...
Flexible hours
.../lead Safety committee meeting to support key decision-making, drive conclusions and develop next steps
Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments
Participate...
Temporary work
Summer work
Summer holiday
Flexible hours
...renewal activities for IL-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications,...
Worldwide
...Title:
Director, Global Regulatory Affairs, Oncology
Company:
Ipsen Bioscience, Inc.
Job Description:
Director, Global Regulatory Affairs, Oncology
Summary / purpose of the position
To be accountable for the strategy, tactics and implementation of...
Temporary work
Local area
Worldwide
Flexible hours
...investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, Alkermes SOPs, and applicable... ...clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data...
Contract work
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in...
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
...have you in front of a live recruiter.
The Opportunity
Description
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Leads development...