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Manager, Regulatory Strategy

Job Description

The Manager, Regulatory Strategy will be responsible for registration and regulatory support of US commercial and development projects.


Job Responsibilities and Requirements:

 

  • Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios
  • Represent Regulatory as a team member, covering CMC, clinical, labeling, and post-approval change activities
  • Provide in-depth reviews of protocols, reports, presentations, press releases, and documents
  • Serve as a primary contact with the FDA; document regulatory contacts with health authorities.
  • Prepare IND, NDA, and BLA submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items.
  • Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
  • Manage timelines to ensure approvals are timely and development objectives are met
  • Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
  • Provide risk assessments and recommendations for various regulatory scenarios
  • Participate in the electronic review and quality verification of regulatory submissions

Minimum Requirements:

  • BS/BA with a minimum of two to five years of regulatory experience; Experience supporting the preparation and filing of a U.S. marketing application (NDA or BLA) is required.
  • Strong English language written and verbal communication skills
  • Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
  • Solid understanding of and experience with electronic Common Technical Document (eCTD) submissions with ability to create content
  • Leadership ability within a team environment
  • Ability to work independently; willingness to voice opinions in the group environment
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
  • Some travel may be required

 

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Job Requirements

 

Job Snapshot

Location US-PA-Philadelphia
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type
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Company Overview

Jazz Pharmaceuticals

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing, and commercializing meaningful products that address unmet medical needs. We have a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. We also support commercial products in other therapeutic areas where we can meaningfully address serious medical needs. As part of our unwavering commitment to improve patients’ lives, we are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. We do this through a growth strategy of growing sales of the existing medicines in our portfolio; acquiring commercial products or product candidates that are in late-stage development; and pursuing focused development of our pipeline of differentiated therapies. Learn More

Contact Information

US-PA-Philadelphia
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Snapshot
Jazz Pharmaceuticals
Company:
US-PA-Philadelphia
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Store Type:

Job Description

The Manager, Regulatory Strategy will be responsible for registration and regulatory support of US commercial and development projects.


Job Responsibilities and Requirements:

 

  • Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios
  • Represent Regulatory as a team member, covering CMC, clinical, labeling, and post-approval change activities
  • Provide in-depth reviews of protocols, reports, presentations, press releases, and documents
  • Serve as a primary contact with the FDA; document regulatory contacts with health authorities.
  • Prepare IND, NDA, and BLA submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items.
  • Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
  • Manage timelines to ensure approvals are timely and development objectives are met
  • Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
  • Provide risk assessments and recommendations for various regulatory scenarios
  • Participate in the electronic review and quality verification of regulatory submissions

Minimum Requirements:

  • BS/BA with a minimum of two to five years of regulatory experience; Experience supporting the preparation and filing of a U.S. marketing application (NDA or BLA) is required.
  • Strong English language written and verbal communication skills
  • Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
  • Solid understanding of and experience with electronic Common Technical Document (eCTD) submissions with ability to create content
  • Leadership ability within a team environment
  • Ability to work independently; willingness to voice opinions in the group environment
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
  • Some travel may be required

 

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Job Requirements

 
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