Sr. Manager, Regulatory Strategy
Company: Jazz Pharma
Location: Philadelphia
Posted on: January 15, 2021
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Job Description:
Overview:Jazz Pharmaceuticals is an international
biopharmaceutical company focused on improving patients' lives by
identifying, developing and commercializing meaningful products
that address unmet medical needs. We are continuing to expand our
commercial product portfolio and our research and development
pipeline in therapeutic areas that can leverage our unique
expertise.Our therapeutic areas of focus include sleep and
hematology/oncology - areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.We are looking for the best
and brightest talent to join our team. If you're looking to be a
part of a company with an unwavering commitment to improving
patients' lives and being a great place to work, we hope you'll
explore our career openings and get to know Jazz
Pharmaceuticals.Responsibilities:Jazz Pharmaceuticals is seeking a
Senior Regulatory Affairs Manager to support the global regulatory
strategy of products in development. The Senior Regulatory Affairs
Manager will be a key member of project teams and will be
responsible for supporting the regulatory activities associated
with products in development.Essential Job Functions:Job
Responsibilities and Requirements:* Participate as an active member
of a multi-disciplinary team to establish development and
regulatory strategies for early stage development programs, late
stage and commercial products.* Represent and coordinate regulatory
information as a team member, covering clinical, CMC, labeling
etc., and general regulatory activities.* Provide in-depth reviews
of protocols, reports, presentations, and other documents.*
Document regulatory activities with FDA and other Health
Authorities.* Prepare IND, NDA, and BLA submissions including
original marketing applications, clinical trial applications,
amendments, supplements, responses to Agency questions and
requests, meeting requests, briefing packages, annual reports etc.
Assist in managing the internal review and submission of these
items.* Ensure consistency/completeness/accuracy, and adherence to
regulations and applicable guidelines for all regulatory
submissions.* Manage submission plans and 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.* Manage regulatory data and information
within systems.* Ensure consistent, completeness and accuracy or
adherence to regulations and applicable guidelines for all
regulatory submissions.Minimum Requirements:* Bachelors, Masters or
advanced degree in a scientific discipline, with at least 5 years
of regulatory strategy experience in the pharmaceutical industry.*
Demonstrated understanding and strategic application of regulations
and guidelines for drug development at IND and NDA/BLA stages.*
Excellent verbal and written communication skills.* Ability to work
with limited supervision and effectively in cross functional
teams.* Excellent organizational and time management skills;
ability to manage multiple complex projects, set priorities and
meet timelines.* Some travel will 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.
Keywords: Jazz Pharma, Philadelphia , Sr. Manager, Regulatory Strategy, Executive , Philadelphia, Pennsylvania
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