The position will also assist in labeling for new products, changes to labeling for existing ... pharmaceutical regulatory affairs (mandatory) Attention to detail Excellent oral and written ...
The position will also assist in labeling for new products, changes to labeling for existing ... pharmaceutical regulatory affairs (mandatory) Attention to detail Excellent oral and written ...
The Associate Director, Regulatory Affairs Labeling Product Leader will be responsible for the ... Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical ...
The Associate Director, Regulatory Affairs Labeling Product Leader will be responsible for the ... Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical ...
The Associate Director, Regulatory Affairs Labeling Product Leader will be responsible for the ... Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical ...
The Associate Director, Regulatory Affairs Labeling Product Leader will be responsible for the ... Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical ...
NJ · On-site
The position will also assist in labeling for new products, changes to labeling for existing ... pharmaceutical regulatory affairs (mandatory) Attention to detail Excellent oral and written ...
NJ · On-site
The position will also assist in labeling for new products, changes to labeling for existing ... pharmaceutical regulatory affairs (mandatory) Attention to detail Excellent oral and written ...
... the pharmaceutical industry. * Proven knowledge of global regulatory submission and approval ... Ability to interpret safety and efficacy data and product labelling requirements. * Strong ...
... the pharmaceutical industry. * Proven knowledge of global regulatory submission and approval ... Ability to interpret safety and efficacy data and product labelling requirements. * Strong ...
Regulatory Labeling & Advertising/Promotion * Safety Sciences Associates will also have ... Pharmaceutical/Biotech industry a plus Exposure or familiarity with evaluating clinical trials ...
Regulatory Labeling & Advertising/Promotion * Safety Sciences Associates will also have ... Pharmaceutical/Biotech industry a plus Exposure or familiarity with evaluating clinical trials ...
Position Description The Associate Labeling Specialist supports regulatory labeling strategy and quality system compliance within the Regulatory Affairs Labeling team at Applied Medical. This role ...
Position Description The Associate Labeling Specialist supports regulatory labeling strategy and quality system compliance within the Regulatory Affairs Labeling team at Applied Medical. This role ...
Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business ... pharmaceutical drug/device labeling. * Contribute labeling strategy to regulatory strategies ...
Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business ... pharmaceutical drug/device labeling. * Contribute labeling strategy to regulatory strategies ...
Director, Regulatory Affairs (Labeling)
$159K - $210K/yr
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that ... The Position The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross ...
Quick apply
Director, Regulatory Affairs (Labeling)
$159K - $210K/yr
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that ... The Position The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross ...
Director, Regulatory Affairs (Labeling)
Pasadena, CA · On-site
$163K - $216K/yr
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that ... The Position The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross ...
Quick apply
Director, Regulatory Affairs (Labeling)
Pasadena, CA · On-site
$163K - $216K/yr
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that ... The Position The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross ...
Director, Regulatory Affairs (Labeling)
Pasadena, CA · On-site
$163K - $216K/yr
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that ... The Position The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross ...
Director, Regulatory Affairs (Labeling)
Pasadena, CA · On-site
$163K - $216K/yr
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that ... The Position The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross ...
Associate Director, Global RA Labeling Lead
Cambridge, MA · On-site
$115.62 - $146.62/hr
Translational Pharmaceutical Sciences and Precision Medicine * The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in ...
Quick apply
Associate Director, Global RA Labeling Lead
Cambridge, MA · On-site
$115.62 - $146.62/hr
Translational Pharmaceutical Sciences and Precision Medicine * The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in ...
Job Responsibilities The Regulatory Labeling Manager - Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products ...
Job Responsibilities The Regulatory Labeling Manager - Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products ...
Director Regulatory Labeling (Contract)
San Diego, CA · On-site
$100 - $200/hr
DIRECTOR REGULATORY AFFAIRS LABELING (Contract) Zentalis is a clinical oncology innovator ... At least 8 years of experience within the biotechnology or pharmaceutical industry with ...
Director Regulatory Labeling (Contract)
San Diego, CA · On-site
$100 - $200/hr
DIRECTOR REGULATORY AFFAIRS LABELING (Contract) Zentalis is a clinical oncology innovator ... At least 8 years of experience within the biotechnology or pharmaceutical industry with ...
DIRECTOR REGULATORY AFFAIRS LABELING (Contract) Zentalis is a clinical oncology innovator ... At least 8 years of experience within the biotechnology or pharmaceutical industry with ...
DIRECTOR REGULATORY AFFAIRS LABELING (Contract) Zentalis is a clinical oncology innovator ... At least 8 years of experience within the biotechnology or pharmaceutical industry with ...
ABOUT THE ROLE The Associate, Registration & Regulatory Compliance, North America (NA) - Home ... Understand and apply label requirements for North America sold goods * Maintains company databases ...
ABOUT THE ROLE The Associate, Registration & Regulatory Compliance, North America (NA) - Home ... Understand and apply label requirements for North America sold goods * Maintains company databases ...
DIRECTOR REGULATORY AFFAIRS LABELING (Contract) Zentalis is a clinical oncology innovator ... At least 8 years of experience within the biotechnology or pharmaceutical industry with ...
DIRECTOR REGULATORY AFFAIRS LABELING (Contract) Zentalis is a clinical oncology innovator ... At least 8 years of experience within the biotechnology or pharmaceutical industry with ...
T he Regulatory CMC Technical Associate may be called upon to author technical reports. The ... of pharmaceutical regulatory affairs experience Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or ...
T he Regulatory CMC Technical Associate may be called upon to author technical reports. The ... of pharmaceutical regulatory affairs experience Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or ...
The Importance of the Role The Associate Director, Regulatory Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed products, and ...
The Importance of the Role The Associate Director, Regulatory Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed products, and ...
Maintain a continued awareness and understanding of FDA, EU, and international health authority regulations, guidance documents with regards to product labeling for pharmaceutical products; assess ...
Maintain a continued awareness and understanding of FDA, EU, and international health authority regulations, guidance documents with regards to product labeling for pharmaceutical products; assess ...
Labeling Pharmaceutical Regulatory Associate information
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Senior Regulatory Affairs Specialist
Jersey City, NJ • On-site
Full-time
Re-posted 4 days ago
Job description
A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
JOB SUMMARY
This will person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products. This position will also interact with other departments and cross functional teams both in US and India.
DUTIES & ESSENTIAL JOB FUNCTIONS
Regulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests.
Independently manage preparation (in paper or electronic formats (eCTD and SPL)), submission and monitoring progress of FDA review of ANDA's
Communication with functional groups for coordination and preparation of data for submission to FDA
Manage all Regulatory, Federal and State License requirements
Review change controls for regulatory requirements and according to appropriate regulations and guidance's.
Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc.)
Review labels as per FDA guidance
Regulatory support in drug listing.
QUALIFICATIONS
BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy
1 - 2 years' experience in pharmaceutical regulatory affairs (mandatory)
Attention to detail
Excellent oral and written communication skills
Knowledge of US drug regulatory requirements (mandatory)
REQUIRED
BS or MS in Sciences or Pharmacy
PREFERRED
Experience with eCTD filings
Regulatory Affairs Certification (RAC)
Candidates having generic drugs and oral dosage experience as well as background preferred
Contact
Ricky Bansal
732-429-1925
About Integrated Resources
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Edison, NJ, US
Year founded
1996