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Alameda Health System
San Carlos, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemAlameda Health System
Oakland, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemNevro
Redwood City
Regulatory Affairs Manager Company: Nevro Location: Redwood City, CA Position Type: Full Time Experience: See below Education: See below Regulatory Affairs Manager at Nevro in Redwood City, CA Req. Master�s deg in RA, Biomedical Eng�g or Med. Devi...
Job Source: NevroHinge Health
San Francisco, CA, United States
Overview: About the Role In this role as a Regulatory Affairs Specialist, you will have responsibility for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain and expand regulatory approval of Hinge Healths medical device portfolio. This Specialist will work with internal and 3rd party ex
Job Source: Hinge HealthHinge Health
San Francisco, CA, United States
Hinge Health is moving people beyond pain by transforming the way it is treated and prevented. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly from their phone. Our approach is proven to reduce pain by 68%, prevent 4
Job Source: Hinge HealthNevro
Redwood City, CA, United States
About Nevro: Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from d
Job Source: NevroMastech Digital
Oakland, CA, United States
Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (Possibility to extend/Convert) Required Qualifications: ● Bachelors degree with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters’ degree may substitute for two
Job Source: Mastech DigitalAlameda Health Sytem
Oakland, CA, United States
SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CD
Job Source: Alameda Health SytemSouth San Francisco, CA, United States
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Key Responsibilities
Responsible for providing regulatory strategy & support for global development.
Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees.
Organize regulatory submissions to health authorities (HAs), including Investigational New Drug (IND)/Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure Agreements (NDA)/Marketing Authorization Applications (MAA), Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, & NDA post-approval submissions.
Responsible for development & implementation of regulatory strategic & tactical planning (RSTP) for assigned on market products or those products in development.
Assist Regulatory Staff by identifying & gathering data to support filings, responses to inquiries, & registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant regulatory HA requirements.
Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development & execution of the regulatory strategy.
Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses during application review.
Write regulatory documents such as meeting requests &/or briefing book activities), & lead draft review meetings.
Advise internal cross-functional team who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Interpret FDA/European Medicines Agency (EMA) regulations, guidelines, policy statements, etc. for drug therapeutics.
Present pertinent regulatory information to appropriate cross-functional areas.
Responsible for operating in compliance with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP).
Qualifications
Must possess a Bachelors degree or foreign academic equivalent in Pharmacy, Biology, Chemistry, Pharmacology or an industry-related field of study with at least 6 years of regulatory, R&D, or industry-related experience, or a Masters degree or foreign academic equivalent in the aforementioned fields of study with 2 years of related regulatory, R&D, or industry-related experience in:
organizing regulatory submissions to health authorities (HAs);
identifying & gathering data to support filings, responses to inquiries, & registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant regulatory HA requirements; &
interpreting FDA/EMA regulations, guidelines, policy statements, etc. for drug therapeutics.
Employer will accept any suitable combination of education, training, or experience.
Salary Range: $178,000 - $208,000 per year
Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF24415P.
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Additional Information
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Email Alert for Regulatory Affairs Manager jobs in South San Francisco, CA, United States
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