Jazz Pharmaceuticals

Senior Manager, Regulatory Strategy (International)

UK-Oxford
1 month ago
ID
2017-1231
# of Openings
1
Category
Research & Development

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. 

Position Profile

A Senior Manager, Regulatory Strategy (International) at Jazz Pharmaceuticals will be a key stakeholder in the company's regulatory activities and initiatives to ensure the quality of regulatory input and implementation for product development and life cycle management. Specifically, in this position, he/she will support Jazz Pharmaceuticals' efforts towards global expansion of our marketed products. The Senior Manager, Regulatory Strategy (International) will oversee select International regulatory projects consistent with the company goals, ensuring timely registration of products in compliance with applicable regulations and guidance. He/she will be responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of new products, changes to existing products and expansion into new international markets in partnership with International Partners.

Essential Functions
  • Creates, evaluates, and completes International regulatory projects consistent with the company goals.
  • Responsible for assembling regulatory submissions and international dossiers to non-EU territories
  • Develop and implement regulatory strategies to facilitate the progress of global expansion of the company’s marketed products
  • Serve as the Regulatory Affairs representative on internal and external project teams; assuring the progression of projects by providing strategy, and feedback to the teams
  • Work with project-specific subject matter experts to successfully interact with international partners and global health authorities, including meeting preparation and communication of commitments and meeting outcomes
  • Manage meetings with marketing partners, and vendors for products/projects
  • Support the company's commercial products, as necessary
  • Maintain awareness of and communicate within the organization changing requirements across the international regulatory landscape (especially with respect to non-EU, emerging markets), updates for regulatory intelligence, and provide regulatory training
  • Represent the company in external forums
  • May manage and/or mentor junior regulatory professionals
Required Knowledge, Skills, and Abilities
  • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
  • Previous experience with global regulatory filings (i.e. Canada, EU, Middle East, Asia-Pacific and South/Central America)
  • Proven track record of effective collaboration with third parties/partners and regulatory agencies to obtain market clearance in other countries
  • Demonstrated success in management of regulatory activities
  • Experience with regulatory agencies and preparation of documentation to support interactions
  • Ability to lead health authority interactions
  • Knowledge and experience in preparation of global regulatory strategies
  • Experience with maintenance of regulatory authorizations and variations in at least two regions
  • Experience working on cross-functional development teams (including Commercial and R&D personnel)
  • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
  • Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others
  • Excellent verbal and written English and communication skills
  • Some travel required
Required/Preferred Education and Licenses
  • Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry
Description of Physical Demands
  • Responsibilities may require working outside of “normal” hours, in order to meet business demands.

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