Senior Manager, Regulatory Affairs

2 weeks ago

Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time
Senior Manager, Regulatory CMC Technical Writing and Submission Management

Responsibilities: The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings. This role requires a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements, while collaborating with cross-functional teams to ensure timely and accurate submissions.

  • Senior Regulatory Affairs Specialist

    4 days ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Omaha, NE, United States Katalyst HealthCares & Life Sciences Full time

    Senior Regulatory Affairs Specialist Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and...