SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Senior Program Manager, Regulatory Affairs - 10194

Company: Simply Biotech
Location: San Diego
Posted on: June 26, 2019

Job Description:

Senior Program Manager, Regulatory Affairs- Simply BiotechOverviewAre you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.Immediate opening for a Senior Program Manager, Regulatory Affairs in San Diego, CA who possesses:Degree in Scientific Discipline and 5+ years of progressive Regulatory Affairs experience in Biotech or Pharmaceutical IndustryExperience with early development regulatory affairs (CMC, Clinical and Generalist Experience) CBER, NDA or BLA preferred experienceDomestic FDA experience required, EU preferred with authoring, coauthoring, reviewing and editing - strong regulatory writing knowledge Email resumes to hyazalou@simplybiotech.com or call 858.496.7758Full DescriptionThe Senior Program Manager, Regulatory Affairs (RA) will provide support to the Executive Director, RA in the development and implementation of regulatory strategies for development products. This individual will support regulatory activities, including strategy development for programs and dossier lifecycle management, and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings. This is a full-time position located at our corporate headquarters in San Diego, CA.The Selected Candidate Will Further PossessStrong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordinglyExcellent operational skills including planning, organizing, and the ability to deal effectively with a variety of personnel both internally and outside the company to drive projects to timely completionExcellent writing, communication, and interpretive skillHigh attention to detail, ability to work on multiple projects with tight deadlines and able to work independentlyPrevious cell therapy product experience and regulatory knowledge is highly preferredPrior direct interactions with Health Authorities is desirableThe Selected Candidate Will Be Responsible For The FollowingEffectively work with internal and external stakeholders to independently manage regulatory activitiesManage, author, coordinate, and review regulatory submission documents and development activities to support regulatory filings and dossier lifecycleIndependently research and interpret regulations, and provide regulatory guidance and strategy to cross-functional stakeholders; monitor clinical, non-clinical, and CMC industry and regulatory trends and be able to apply learnings and provide guidance or strategy related to such trendsLead and manage the strategy and preparation of health authority meeting materials and responses to requests for informationSupport management with development and implementation of departmental strategies and policies, and contribute to the development and implementation of regulatory strategies to mitigate risksAssure compliance with all applicable (domestic and international) regulationsMay mentor or lead other department staffOther duties as assignedWorking Conditions And Physical RequirementsMay require occasional evening and weekend workFull-time onsite work at Company's headquarters in San DiegoMay require occasional travel for training programs and meetingsFor immediate and confidential consideration, please email your resume to hyazarlou@simplybiotech.com or call 858.496.7758More information can be found at www.simplybiotech.comSimply Biotech specializes in recruiting exclusively for the biotech community.by Jobble

Keywords: Simply Biotech, San Diego , Senior Program Manager, Regulatory Affairs - 10194, Executive , San Diego, California

Click here to apply!

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

I'm looking for
in category
within


Other Executive Jobs


Product Manager 2
Description: Job Location US-CA-San Diego Job ID 19-9092 Type Regular Hire Company Overview Mitchell is a trusted software and service provider to the Property Casualty Claims and collision repair industries as (more...)
Company: Medical Consultants Network
Location: San Diego
Posted on: 07/21/2019

Program Manager, New Product Development --- Biomedical Instruments
Description: Program Manager, New Product Development - Biomedical Instruments INV Invetech has been creating breakthrough products and custom automation systems for more than 30 years. With experience drawn (more...)
Company: Fluke Networks
Location: San Diego
Posted on: 07/21/2019

Customer Service Manager
Description: Customer Service Manager Job Description Activbody aspires to provide efficient, effective and engaging solutions to enhance fitness and health. For everyone. A revolution in daily fitness, wellness and (more...)
Company: Activbody, Inc.
Location: San Diego
Posted on: 07/21/2019


Counter Manager
Description: This is an exciting job opportunity with Giorgio Armani Fragrance in
Company: AllWork
Location: San Diego
Posted on: 07/21/2019

Spectrum Area Manager
Description: Date posted 07/09/2019 Requisition Number: BR-4 Location: United States - California - San Diego Area of Interest: Retail, Sales Position Type: Full Time JOB SUMMARY R esponsible for building, owning (more...)
Company: NaviSite
Location: San Diego
Posted on: 07/21/2019

Manager in Training - South San Diego County
Description: Accelerate your potentialGeared for the DrivenInterested in a rewarding career with great pay, outstanding benefits and the opportunity to grow Henley Enterprises, Inc. a franchisee of Valvoline Instant (more...)
Company: Henley Enterprises, Inc
Location: Chula Vista
Posted on: 07/21/2019

Infrastructure Manager
Description: Scientific Research Corporation is an advanced information technology engineering company that provides innovative products and services to government and private industry, as well as independent institutions. (more...)
Company: Scientific Research Corporation
Location: San Diego
Posted on: 07/21/2019

Director of Finance
Description: POSITION SUMMARY:Under the supervision of the CFO, the Director of Finance analyzes, prepares and summarizes financial results to ensure the achievement of short- and long-term financial goals. As a key (more...)
Company: Airgain, Inc.
Location: San Diego
Posted on: 07/21/2019

Case Manager - LVN
Description: Seeking Licensed Vocational Nurses LVN to be a Care Coordinator for our fantastic home health team.-- Join
Company: Cameron Craig Group
Location: La Mesa
Posted on: 07/21/2019

Senior Property Manager
Description: Job TitleSenior Property Manager br Job Description SummaryResponsible for the management of the Property Management staff as well as to oversee a significant portfolio or property and to serve as a (more...)
Company: Cushman & Wakefield, Inc.
Location: San Diego
Posted on: 07/21/2019

Log In or Create An Account

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

San Diego RSS job feeds