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Associate Manager, Regulatory Affairs & Quality for Medicines360 
Posted April 28, 2022

Job Type:
Full Time, Exempt (Contractor)

Job Title:
Associate Manager, Regulatory Affairs & Quality 

Job Description:
Reports To: Associate Director, Regulatory Affairs
In Office Presence: 0%
 
POSITION SUMMARY:
The Associate Manager, Regulatory Affairs and Quality is responsible for working closely with members of the Regulatory and Quality teams to support preparation and maintenance of drug and drug-device combination product dossiers in the United States and low- and middle-income countries (LMICs). They provide support for applications and submissions to regulatory agencies, granting agencies, and/or non-governmental organizations (NGOs) covering activities from pre-submission to post-approval. They will also provide regulatory and quality support for new product assessment and development. They also assist with the maintenance of regulatory compliance files, archives, and recordkeeping systems.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Supports the preparation of regulatory submissions and correspondence in the US and LMICs
• Collection and organization of information for regulatory and quality documents
• Contributes to and reviews product labeling (artwork and printer proofs) for submissions and commercialization
• Consolidates, tracks, and archives regulatory correspondence and documentation for long-term storage and retrieval 
• Gathers, reviews, and summarizes CMC information in support of change controls, regulatory submissions, and quality activities
• Support pharmacovigilance activities through case tracking and reconciliation
• Tracks and archives regulatory files and records necessary to maintain compliance
• Engages as a member of the regulatory and quality inspection team and supports inspection activity
• Assists with management of public clinical trial information
• Performs research on product regulatory history, organization quality performance, and regulatory framework for new products
• Assist with gathering and organizing information and documents needed for submission to granting agencies or non-governmental organizations (NGOs)
• Extract information from source documents or regulatory submissions to address specific queries related to CMC, regulatory, and quality issues
• Assists with the management of the eTMFs through QC and archival activities
• Provides support for contracting process with Legal, including following internal procedure to request new and amended contracts
• Performs regulatory intelligence activities:
• Monitors current and changing regulatory legislation, guidance, and practices
• Summarizes updates and communicates them on a regular basis to their regulatory report
• Supports Regulatory and Quality teams and assumes assigned responsibilities for routine and non-routine regulatory and quality tasks 

ESSENTIAL SKILLS & QUALIFICATIONS:
• A. or B.S. degree in a scientific or similar relevant field, or equivalent qualification and experience 
• Minimum 2-4 years related regulatory, quality, and/or clinical trial experience
• Prior experience successfully preparing regulatory applications is preferred
• Requires working knowledge and understanding of CMC sections of the eCTD, ICH guidelines, GXP principles, and FDA regulations and guidelines
• Strong organizational and technical skills (e.g., strong skills and proficiency with MS Office, Adobe Acrobat, SharePoint, databases, online research) 
• Experience with Veeva or similar EDMS systems for management of quality and regulatory documentation 
• Ability to function with moderate to minimal supervision, show initiative, problem solve, and identify issues and propose pragmatic solutions to resolve
• Ability to prioritize multiple assignments in a fast-paced office environment 
• Ability to work independently as well as a team player cross-functionally
• Excellent verbal, written and communication skills

 PHYSICAL DEMANDS/MISC: 
• Ability to sit at a workstation for an extended period (in-office or remote)
• While performing the duties of this job, the employee may need to, stand, sit, stoop, walk; talk, hear, reach and use hands and fingers to operate a computer keyboard

Compensation:
TBD

Employer Contact:
Apply Online

Employer Name:
Medicines360

Employer City / Location:
Remote, California

Employer Website:
Medicines360

Company Description:
Medicines360’s mission is to remove cost as a barrier to health by developing and providing affordable Women’s Health products.

Medicines360 is a different kind of pharmaceutical organization. We are a San Francisco-based nonprofit women’s health pharmaceutical organization with a mission of expanding access to quality medicines for all women.

Medicines360 has developed a groundbreaking approach to expand access.  It starts with our nonprofit mission and exclusive focus on expanding access to quality medicines for all women, regardless of socioeconomic status, insurance coverage or geography. We research the health needs of women and gaps in access and develop quality women’s products to fill those gaps. We form key partnerships with companies to help distribute and market these medicines in the US and globally, and in a way that expands access for all women, regardless of socioeconomic status or insurance coverage. We then reinvest the proceeds from those partnerships into advocacy, education, and research and development of other products to further expand access.

Medicines360 is proud to be a leader in expanding access to quality medicines for women.  We believe that by supporting the products and partnerships we develop, everyone can play a role in expanding access to quality medicines and make a difference in the lives of women, everywhere.