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BioTalent
, CA, United States
This individual will join our client's regulatory team and collaborate with other departments like R&D, Manufacturing, Quality Assurance, and Commercial. Here's what you'll be responsible for: Preparing Regulatory Submissions: You'll draft submissions for international markets and the FDA, including Technical Documents, Files, Device Applications
Job Source: BioTalentAbbott Laboratories company
Los Angeles, CA, United States
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Source: Abbott Laboratories companyBioSpace, Inc.
Los Angeles, CA, United States
Job Details HOW MIGHT YOU DEFY IMAGINATION? At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to le
Job Source: BioSpace, Inc.Confidential
Los Angeles, CA, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA interact
Job Source: ConfidentialAmgen Inc. (IR)
Los Angeles, CA, United States
Executive Director, Regulatory Affairs page is loaded Executive Director, Regulatory Affairs Apply remote type Remote locations US - California - Los Angeles time type Full time posted on Posted 2 Days Ago job requisition id R-190059 Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMA
Job Source: Amgen Inc. (IR)Abbott Laboratories
Los Angeles, CA, United States
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of . Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An
Job Source: Abbott LaboratoriesConfidential
Los Angeles, CA, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
Job Source: ConfidentialConfidential
Los Angeles, CA, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Geno
Job Source: Confidential, CA, United States
Meets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group. The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departments to develop and implement regulatory strategies for the company's rare disease development programs. The position will be onsite 3x per week.
Responsibilities:
Providing strategic and operational regulatory support for collaboration with project team members, including regulatory colleagues.
Contributing to regulatory plans and strategies, proposing risk mitigation strategies, and influencing project teams across international locations.
Assist in the development and implementation of strategies for early regulatory approvals, preparing and managing technically complex submissions, offering regulatory advice to cross-functional teams, leading the drafting of responses to regulatory queries, and staying updated on regulatory requirements to communicate changes to other departments.
Qualifications:
Life Sciences Degree (MSc, MPH, PhD - preferred)
10 years of experience in pharmaceutical regulatory affairs, specifically in CMC regulatory affairs, with a strong track record in contributing to regulatory submissions.
Experience in small company settings and fast-paced environments is preferred.
Proficiency in MS Word, Excel, PowerPoint, Visio, and Adobe Acrobat, along with experience in document formatting templates, is necessary.
Regulatory experience in the development of modified-release solid oral dosage forms is highly preferred, and experience with small molecule development is required.
Send a copy of your updated resume to [email protected] to discuss the details further.
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Email Alert for AD/Director Regulatory Affairs jobs in , CA, United States
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