Current jobs related to Associate, Regulatory Affairs - Hawthorne NY - Sun Pharma (Taro Pharma)

  • Senior Associate, Regulatory Affairs

    2 months ago

    Hawthorne, NY, United States Taro Pharmaceuticals Inc Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests,...

  • Senior Associate, Regulatory Affairs

    2 weeks ago

    Hawthorne, NY, United States Taro Pharmaceuticals Inc Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Senior Associate, Regulatory Affairs

    2 months ago

    Hawthorne, United States Taro Pharmaceuticals Inc Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Senior Associate, Regulatory Affairs

    2 months ago

    Hawthorne, United States Taro Pharmaceuticals Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Senior Associate, Regulatory Affairs

    2 months ago

    HAWTHORNE, United States Taro Pharmaceuticals Inc Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Senior Associate, Regulatory Affairs

    2 months ago

    Hawthorne, United States Taro Pharmaceuticals Inc Full time

    Job DescriptionResponsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hawthorne, New York, United States Taro Pharmaceuticals Inc Full time

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Taro Pharmaceuticals Inc. This role will be responsible for preparing, reviewing, and submitting regulatory documents to the FDA, as well as supporting various activities in the department related to regulatory submissions and R&D requests.Key...

  • Senior Associate, Regulatory Affairs

    8 hours ago

    Hawthorne, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests,...

  • Senior Associate, Regulatory Affairs

    1 month ago

    Hawthorne, NY, United States Taro Pharmaceuticals Inc Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Senior Associate, Regulatory Affairs

    2 months ago

    Hawthorne, NY, United States Taro Pharmaceuticals Inc Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Senior Associate, Regulatory Affairs

    2 weeks ago

    Hawthorne, NY, United States Taro Pharmaceuticals Inc Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Regulatory Affairs Specialist

    1 week ago

    Hawthorne, California, United States Taro Pharmaceuticals Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Taro Pharmaceuticals. The successful candidate will be responsible for preparing, reviewing, and submitting regulatory documents to the FDA, as well as providing regulatory support for post-marketing commercial activities.Key ResponsibilitiesPrepare and submit new...

  • Compliance and Regulatory Affairs Manager

    3 weeks ago

    Hawthorne, California, United States FSO SKILLED PERSONNEL Full time

    Job DescriptionFSO Skilled Personnel is seeking a highly skilled and experienced Quality Control Supervisor to join our team.Key Responsibilities:Manage daily quality functions in the department, ensuring compliance with regulatory requirements and company policies.Monitor and oversee performance to ensure tasks are completed during daily needs, identifying...

  • Specialist, Regulatory Affairs

    3 months ago

    New York, NY, United States Shiseido Full time

    Job Summary: The Specialist Regulatory Affairs is responsible for ensuring that the assigned Brand products meet and follow all regulatory requirements necessary to conduct business globally.  This role will work on Shiseido and Cle De Peau Beaute brands.                       Primary Duties & Responsibilities: Gathering, generating and...

  • Regulatory Compliance Specialist

    1 month ago

    Hawthorne, California, United States South Bay Workforce Investment Board, Inc. Full time

    Job OverviewThe South Bay Workforce Investment Board, Inc. (SBWIB, Inc.) is in search of a meticulous and organized Regulatory Compliance Specialist to enhance our Contracts division. The ideal candidate will possess a background in contract oversight, demonstrate exceptional analytical capabilities, and show a strong commitment to detail. This role requires...

  • Regulatory Compliance Specialist

    1 month ago

    Hawthorne, California, United States South Bay Workforce Investment Board, Inc. Full time

    Job OverviewThe South Bay Workforce Investment Board, Inc. (SBWIB, Inc.) is in search of a meticulous and analytical Regulatory Compliance Specialist to enhance our Contracts division. The successful candidate will possess a background in contract oversight, exhibit strong evaluative capabilities, and demonstrate exceptional attention to detail. This role...

  • Manager, Regulatory Affairs

    3 months ago

    New York, NY, United States Shiseido Full time

    Job Summary:  This manager will serve as liaison between DDG brand holder and HQ regulatory team on the DDG medical devices regulatory compliance evaluation and registration ensuring all the products for registration meet and follow all regulatory requirements necessary to conduct business globally. The Regulatory Manager is also responsible for the...

  • Dentist (Associate Chief of Dental)

    4 weeks ago

    Bath, NY, United States Department Of Veterans Affairs Full time

    Duties VA offers a comprehensive total rewards package. Duties Include: Working with Dental Chief for planning, developing, coordinating, directing, and evaluating the clinical services of the Dental Service Line.Performing wide-range and higher-level management functions through participation in planning and oversight boards, councils, and...

  • Product Development Associate

    3 weeks ago

    Hawthorne, New York, United States Taro Pharmaceuticals Inc Full time

    **Job Summary**The Product Development Associate role at Taro Pharmaceuticals Inc. is a key position within the OTC Business unit, responsible for driving innovation and supporting the development of new products. This role will facilitate critical activities to meet customer and market requirements, while ensuring timely completion of development...

  • Associate Registrar

    2 weeks ago

    Hudson, NY , USA, United States Columbia Greene Community College Full time

    About the RoleColumbia-Greene Community College is seeking a highly skilled and detail-oriented Associate Registrar to join our team. As a key member of our Office of Records and Registration, you will play a critical role in ensuring the accuracy and integrity of student records.Key ResponsibilitiesDeputy Registrar: Provide support to the Registrar on an...

Associate, Regulatory Affairs

4 months ago

Hawthorne NY, United States Sun Pharma (Taro Pharma) Full time

The Associate, Regulatory Affairs - Labeling position is responsible for the preparation of various regulatory Labeling submissions.

 

Area of Responsibility:

 

  1. Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
  2. Prepare and submit updated labeling in eCTD format to the FDA
  3. Review labeling revisions for Taro and private label products.
  4. Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS).
  5. Convert Taro labels and customers labels to SPL.
  6. Prepare Drug Listings for newly approved and private label products and resolve returned listing problems.
  7. Reserve NDC numbers for Taro and customer labeling.
  8. Monitor FDA web sites for revisions to labeling for RLD of Taro products.
  9. Assist with customs release inquiries.
  10. Track and advice of all labeling revisions for incorporation into annual reports.
  11. Respond to requests for information regarding marketed prescription and OTC products.
  12. Maintain documents on approved and newly filed products.
  13. Electronically search for new regulatory guidelines and regulations. Perform routine monitoring of Federal Register.
  14. Assist with review, approval and submission of Promotional Materials for Taro Products.
  15. Assist with projects such as FDA inspection, teleconferences arranging webinars, etc.
  16. Collect information to assist in compiling departmental budget.

 

Education and Job Qualifications:

 

  • Bachelor's degree, in scientific field preferred.
  • Minimum 1-3 years regulatory experience in the generic pharmaceutical industry.
  • Advanced computer skills required.
  • Solid written communication skills and the ability to work independently in preparation of regulatory documents and correspondence.

 

The presently-anticipated base compensation pay range for this position is $67,000 to $82,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

 

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.