OxnardRecruiter
the smart solution for Oxnard jobs

Regulatory Affairs Associate

Company: Tech Observer
Location: Oxnard
Posted on: October 8, 2018

Job Description:

Experience (Preferred) Database management experience Regulated industry, science academia or clinical practice experience Job Summary: -Will assist in the creation and submission of regulatory documents and may be the US regulatory lead for a program under the supervision of a more experienced regulatory lead. -In the initial weeks of employment in this role, there will be onboarding training available from fellow US Regulatory Professionals and other staff members to familiarize the new hire with the following: Company systems, processes and template documents; expectations and responsibilities of the US Regulatory Professional role; activities regarding the assigned programs, etc. Key Activities: Assist US Regulatory Lead to support regional regulatory activities (e.g. dossier development and submission, advisory committee meeting preparations) Provide and maintain Clinical Trial Application (IND) and Marketing Application (NDA and/or BLA) documentation support (e.g. annual reports, amendments) in collaboration with US Regulatory Lead Create and maintain product regulatory history documents through IMR database and appropriately archive all regulatory documents and agency communications Review US regional component of the Global Regulatory Plan and provide input to operational deliverables Ensure compliance with submissions to regulatory agencies (FDA) Collaborate to support site initiation Coordinate collection of functional documents in support of regulatory applications As appropriate participate in Global Regulatory Team (GRT) to support execution of regulatory strategy Coordinate QC of regulatory documentation (e.g. briefing packages) Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) Prepare cross-reference letters to support investigator initiated studies Complete regulatory forms to support agency communications (e.g. FDA form 1571) Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams Support process improvement initiatives, standards development, and metrics Assist in template development and maintenance Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams Actively support regulatory compliance Support the development and execution of GRT goals Education and Experience: Masters degree OR Bachelors degree and 2 years of regulatory and/or drug development experience OR Associate's degree and 6 years of regulatory and/or drug development experience OR High school diploma and 8 years of regulatory and/or drug development experience

Keywords: Tech Observer, Oxnard , Regulatory Affairs Associate, Other , Oxnard, California

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


Work From Home Jobs - Drive with Lyft - $250 Bonus Available
Description: What is Lyft br br Lyft matches drivers with passengers who request rides through the Lyft smartphone app. Signing up to be a Lyft driver is the perfect opportunity for you to set your own schedule (more...)
Company: Lyft
Location: Claremont
Posted on: 10/16/2018

Security Officer (7020)
Description: The ideal candidate for this position will hold a valid Active Guard Card in order to work. We are looking for those with good communication and customer service skills. A person in this role can expect (more...)
Company: U.S. Security Associates
Location: Pomona
Posted on: 10/16/2018

Security Officer (6912)
Description: Security Officer needed with active Guard Card U.S. Security Associates, the market leading and wholly owned American safety and security services provider, has Security Officer openings in your area (more...)
Company: U.S. Security Associates
Location: North Hollywood
Posted on: 10/16/2018


Specialist, Community Affairs
Description: Overview:Under the direction of the Director, Community Affairs, the Specialist, Community Affairs will be responsible for maintaining and cultivating relationships with local private, civic, and public (more...)
Company: AltaMed
Location: Los Angeles
Posted on: 10/16/2018

Manufacturing Internship (Unpaid - for school credit)
Description: Manufacturing Engineer Intern br br Summary: br br ul br br li Assist MFE members with
Company: Motorsport Aftermarket Group
Location: Santa Fe Springs
Posted on: 10/16/2018

Professional Landscapers - Grow Your Business With HomeAdvisor (North
Description: Professional Landscapers - Grow Your Business With HomeAdvisor North Over 25 million homeowners
Company: HomeAdvisor
Location: North Hollywood
Posted on: 10/16/2018

Security Officer (6832)
Description: Security Officer needed with active Guard Card Andrews International a U.S. Security Associates Company, the market leading and wholly owned American safety and security services provider, has Security (more...)
Company: U.S. Security Associates
Location: Los Angeles
Posted on: 10/16/2018

Bilingual Customer Care - Hurricane Relief
Description: Bilingual Customer Care - Hurricane Relief We have immediate openings for bilingual Customer Service Representatives to assist the thousands of Americans affected by the devastation of recent hurricanes (more...)
Company: Mommy Jobs Online
Location: Glendora
Posted on: 10/16/2018

Mobile Associate - Bilingual, Spanish (Part-Time)
Description: Job Description: Mobile Associate MA work as part of a Retail Team of Experts to bring the T-Mobile brand to life. They live and breathe T-Mobile Theyre brand ambassadors who create energy and excitement (more...)
Company: T-Mobile
Location: Laguna Niguel
Posted on: 10/16/2018

Professional Landscapers - Grow Your Business With HomeAdvisor (Torran
Description: Over 25 million homeowners have trusted HomeAdvisor to help them find quality professionals
Company: HomeAdvisor
Location: Torrance
Posted on: 10/16/2018

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Oxnard RSS job feeds