Current jobs related to Senior Associate, Regulatory Affairs - Hawthorne NY United States - Taro Pharmaceuticals Inc

  • Senior Associate, Regulatory Affairs

    3 weeks ago

    Hawthorne, NY, 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

    6 days ago

    Hawthorne, NY, 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...

  • Senior Associate, Regulatory Affairs

    1 week ago

    Hawthorne, NY, 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...

  • Senior Associate, Regulatory Affairs

    4 weeks ago

    Hawthorne, NY, 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...

  • Senior Associate, Regulatory Affairs

    3 weeks ago

    Hawthorne, NY, 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...

  • Senior Associate, Regulatory Affairs

    1 month 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

    3 weeks 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...

  • Senior Associate, Regulatory Affairs

    6 days 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...

  • Senior Associate, Regulatory Affairs

    6 days 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...

  • Senior Associate, Regulatory Affairs

    3 weeks 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...

  • Senior Associate, Regulatory Affairs

    2 weeks 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...

  • Senior Associate, Regulatory Affairs

    3 weeks 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...

  • Senior Associate, Regulatory Affairs

    2 weeks ago

    Hawthorne, United States Sun Pharmaceutical Industries, 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...

  • Senior Associate, Regulatory Affairs

    1 week ago

    Hawthorne, CA, 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...

  • Senior Director of Regulatory Affairs

    4 weeks ago

    New York, NY, United States MetroPlusHealth Full time

    Empower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest...

  • Regulatory Affairs Specialist

    2 weeks ago

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

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Sun Pharmaceutical Industries, Inc. This role 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...

  • Regulatory Affairs Specialist

    2 weeks ago

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

    Job SummaryWe are seeking a highly skilled Senior Associate, Regulatory Affairs to join our team at Sun Pharmaceutical Industries, Inc. This role 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...

  • Senior Associate, Regulatory Affairs

    3 weeks ago

    ARMONK, NY, 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...

  • Regulatory Affairs Specialist

    1 week ago

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

    Job DescriptionAs a Senior Associate, Regulatory Affairs, you will be responsible for preparing, reviewing, and submitting new ANDAs, NDAs, DMFs, INDs, Supplements, and responses to FDA's deficiencies. You will also support various activities in the department related to regulatory submissions and R&D requests, and collaborate with other departments within...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    , GA, United States Abbott Full time

    About AbbottAbbott 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...

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, and supporting other departments within the organization. Make consistent, sound regulatory assessments of proposed changes requested by operations or R&D.

Duties and responsibilities

  1. Responsible for preparation, compilation, review and submission of new NDAs, ANDAs, DMFs and INDs in eCTD format for FDA submission. Write related module (Mod 1) in CTD format for NDA, ANDA, DMF and IND. The submission content, style and architecture should adhere to electronic common technical document (eCTD) format. Follow current FDA and ICH guidelines and current cGMP and GLPs, pharmaceutical product testing requirements. Refer to USP requirements for chemical, physical and microbiological testing.
  2. Prepare, and submit INDs, NDAs, ANDAs, DMFs and ANADA annual reports, amendments and supplements in eCTD compliant format. Submissions should be prepared and reviewed for accuracy, consistency, and conformance to FDA and 21CFR regulations, ICH guidelines and in-house SOPs.
  3. Regulatory support of post-marketing commercial activities. Prepare and review supplements (PASs, CBE-30 and CBEs) for FDA submission. Review and approve change control forms for post approval activities of the product. Utilize regulatory and scientific skills to evaluate changes (such as changes to an approved product). For example: container closure system, manufacturing process, specifications, components and composition, and provide regulatory assessment based on current FDA and ICH guidelines, 21CFR regulations, USP requirements (for USP products and APIs).
  4. Evaluate prototype formulations for future filings based on IID database, RLD labeling, RLD patent(s) and exclusivities.
  5. Prepare Controlled Correspondences for FDA submission based on information provided by R&D department. The document should be prepared by utilizing scientific rational and supporting data provided by R&D department.
  6. Write SOPs.
  7. Maintain database.
  8. Other duties as assigned.

Qualifications

  1. Three to five years of regulatory experience in pharmaceutical industry is required.
  2. Bachelor's or Master's Degree in a scientific discipline or equivalent.
  3. Strong written and verbal communication skills necessary.
  4. Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
  5. Ability to work effectively in a highly charged, fluid environment.
  6. Knowledge of Windows based software programs such as Word, Excel.
  7. Familiarity with FDA website is important in order to accomplish daily tasks.