...North America (US/CAN), provides regulatory guidance and advice on... ...introduce new products to market. Manages notifications and submissions to... ...with the training of regulatory affairs personnel and provides direction on specific projects. Assures all internal reporting...
Suggested
Local area
...The Regulatory Affairs Specialist will be the regulatory representative for assigned due diligences... ...development through life cycle management.
Responsible for developing and maintaining... .... This would involve working with a project team, integrating regional...
Suggested
Contract work
...LMI is seeking an experienced Regulatory Affairs Manager to support our Joint Program Executive Office for Chemical, Biological, Radiological... ...Assess results and progress relative to objectives across projects and communicate periodically/as needed to relevant leadership...
Suggested
Full time
Contract work
Remote job
Flexible hours
...background not just lab but manufacturing and process development.
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product...
Suggested
Remote job
Flexible hours
...Responsibilities arrow_right
Provide regulatory excellence to the organization and guide decision making
Responsible... ...direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and balanced....
Suggested
Remote job
Work from home
Home office
...will be a 100% remote role
The hiring manager confirmed they are looking for someone... ...experience with the Six Sigma method and project management experience.
The type of qualities... ...of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
Work with stakeholders...
Suggested
Work experience placement
Remote job
Shift work
...responsible for the development and life cycle management of combination products/devices. The candidate utilizes expertise to provide Regulatory CMC global regulatory strategy, support... ...support to ensure the delivery of project and business objectives.
Participates...
Suggested
Part time
Shift work
Day shift
...-provided short-term disability, an employee assistance program, and a wellness program.
Position Overview:
The Counsel – Regulatory Affairs is responsible for supporting compliance with federal and state laws and regulations. Counsel – Regulatory Affairs will be expected...
Suggested
Temporary work
Local area
...where you can work across functions and on a wide-variety of projects? As a member of Stryker’s RA/QA team, that is exactly what... ...Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team :
We are proud to be named one of...
Suggested
Holiday work
Temporary work
Local area
Remote job
Flexible hours
...Summary Description
# Independently provide EU regulatory requirements and guidance to EU MDR project teams.
# Lead the preparation of the EU... ...~ Under minimal supervision of Sr. Manager or Director of Regulatory Affairs
Supervision Exercised
~ None
Essential...
Suggested
Shift work
Day shift
...Job Title: Sr. Regulatory Affairs Consultants
Location: (100% remote)
Duration: Long Term... ...met throughout the product lifecycle.
Manage regulatory submissions and approvals... ..., EU MDR, and ISO standards.
Strong project management skills with the ability to prioritize...
Suggested
Remote job
...for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's... ...as needed.
Responsibilities
Manages, directs, and drives the strategy... ...of experience within Regulatory Affairs
~ Knowledge of IND, NDA/BLA submission...
Suggested
Full time
Kavaliro's client is seeking a Sr Project Manager.
Responsibilities:
Project Planning and Initiation:
Develop comprehensive project plans, defining scope, objectives, timelines, and deliverables.
Collaborate with....
#
Suggested
...TECHNICAL SKILLS
Must Have
~ Advertising and Promotional Regulatory Assessment experience, change control, and US/EU submission... ...in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired...
Suggested
Remote job
Contract work
Immediate start
...:
FULLY REMOTE
Job Details:
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that... ...development.
Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions.
Tasks may...
Suggested
Remote job
...insights for enhanced patient and practice management.
Nevro also recently added a... ...the SF Bay Area)
The Principal Regulatory Affairs Specialist will be part of this high-... ...Support New Product Development on project teams on behalf of RA, developing and...
Full time
Temporary work
Relief
Worldwide
Night shift
...CTA filings.
Reporting to our SVP, Regulatory Affairs, you will positively impact patients’... ...excellence of all CTAs
Oversee and manage all CRO contributions to Karyopharm’s CTAs... ...asset
Strong organizational and project management skills is important
Demonstrated...
Holiday work
Full time
Work experience placement
Immediate start
..., an employee assistance program, and a wellness program.
Position Overview:
The EVP, Regulatory Affairs Counsel is responsible for ensuring that company’s compliance management program comports with federal and state law. This role will provide leadership and direction...
Temporary work
Local area
...immune disorders.
Summary
The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function,... ...GRA's data strategy with broader corporate IT projects and objectives
Collaborate with Corporate...
Full time
...Managing Counsel
Syneos Health® is a leading fully integrated biopharmaceutical... ...unique clinical, medical affairs and commercial insights into... ...for a detail-oriented regulatory attorney to join its Legal... ...and driving corporate legal projects to completion.
• Supports the...
$75k - $80k
...If you are a remote Regulatory Affairs Specialist with strong electrical and other engineering product standards to help put together our... ...Device Manufacturer with the first FDA approved non-toxic pain management system that offers a critical alternative to the Opioid...
Full time
Relief
Immediate start
Remote job
...data protection.
We are seeking an experienced Quality & Regulatory Compliance Manager to advance our compliance team's mission of ensuring that... ...four (4) years of professional experience in regulatory affairs or in quality management systems relating to medical devices...
Remote job
Full time
Worldwide
...What Regulatory Affairs contributes to Cardinal Health
Regulatory provides regulatory affairs... ...Perform other duties and projects assigned as needed.
Qualifications... ...excellent organizational skills; project management skills preferred
~ Excellent interpersonal...
Remote job
Full time
Temporary work
Work experience placement
Local area
Flexible hours
...Companies (TTC) are a leading payroll, business affairs & technology provider to the advertising... ...is created.
Sr. Business Affairs Manager
Regular Full-Time
Position... ...our clients
~Lead or assist on large projects that fall within your area of expertise...
Full time
Contract work
Work experience placement
Gangs
$85k - $90k
...If you are a Sr Regulatory Affairs Specialist with strong medical device experience looking for a 100% Remote role you must read on!
Headquarters... ...Manufacturer with the first FDA approved non-toxic pain management system that offers a critical alternative to the Opioid...
Full time
Relief
Immediate start
Remote job
...Description:
Note:
FULLY REMOTE
Regulatory Writing Senior Manager
~ ln this vital role role you will serve as the functional area lead on... ...preferred
~ Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
~5+years of...
Contract work
Freelance
Remote job
...This Role
This role is responsible for Regulatory CMC expertise into the development and... ...planning for the CMC aspects of assigned projects/products. Responsibilities include... ...activities in the assigned regions and managing of routine and non-routine Health Authority...
Full time
Local area
Remote job
...Senior Project Manager
Syneos Health® is a leading fully integrated biopharmaceutical solutions... ...We translate unique clinical, medical affairs and commercial insights into outcomes... ...Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison...
Contract work
Easy work
...partner across Commercial, Medical Affairs and Government Affairs (CMG) to... ...operations of our translation projects, working closely with the Translation Program Manager and coordinating with... ...submission of translated materials for regulatory review and approval, ensuring...
Remote job
Contract work
Work experience placement
...independent assurance on Varo’s governance, risk management practices, and internal controls. We will also conduct special advisory projects. As Varo is the first consumer fintech to... ..., and a comprehensive understanding of regulatory requirements and industry best practices....
Full time
Remote job