North American Lead Rare Disease: Senior Director, Global Regulatory Affairs (GRA)

Bridgewater, NJ

Posted: 08/12/2019 Industry: Biotech/R&D/Science Job Number: 49384


North American Lead Rare Disease: Senior Director, Global Regulatory Affairs (GRA) 
The Senior Director of North America Regulatory Strategy (NA GRA) will be primarily responsible for the development of US regulatory strategy to advance Rare Disease and Rare Blood Disorders portfolios of development pipeline candidates and life cycle management of marketed products.  Reporting to the Associate Vice President of North America Regulatory Affairs, this individual will work within the Global Regulatory Team to provide strategic input and ensure operational execution of US submission activities for the Rare Disease portfolio. The individual will be responsible to interface directly with the US FDA as the primary contact for the company for assigned programs and lead a small team of North America Regulatory Leads (NARLs).  The position may be based at either Bridgewater, NJ or Cambridge, MA.  
  • Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for Rare Disease and Rare Blood Disorders indications which adhere to US regulatory and company  guidelines. 
  • Have  an understanding of  the competitive environment of the various rare disease indications and support NARLs in developing products that are differentiated and provide commercial value as well as value for the  patient 
  • Represent  the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy  documents. 
  • Lead  the strategic development of briefing materials and prepare teams for US FDA  meetings. 
  • Accountable  to define document content/strategy to align with US regulator  expectations. 
  • Participate  in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs. 
  • Represent  company  US FDA for assigned projects. 
  • Work with the NA labeling strategist Global Regulatory Team Leads, and the Global Regulatory Team to develop US prescribing information. 
  • Work  with and participate on multi-disciplinary matrixed teams to successfully meet project US regulatory deliverables while adhering to regulatory requirements for programs and  products. 
  • Consult  with senior management to develop and communicate regulatory strategies and advice for products and  programs. 
  • Participate  in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US  regulations. 
  • Function as a player/coach with an ability and willingness to perform dossier/submission management tasks and develop high level regulatory strategy for assigned projects. 
  • Supervise, and/or coach mentor, junior staff supporting regulatory  team. 
  • Ensure compliance with all regulatory and internal policies  

  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult  positions. 
  • Solid  knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and  guidance 
  • Direct  interaction/negotiation with regulatory authorities (e.g.  FDA) 
  • Ability  to motivate and lead  others 
  • Team  player, ability to work well within cross-functional teams and in a multicultural/multinational  environment 
  • Excellent  oral communication and writing  skills 
  • Change management/ change  enabler:  embraces the challenges of a fast changing environment 
  • Generates  innovative solutions in work situations, trying different and novel ways to deal with work problems and  opportunities 
  • Excellent  operational  skills 
  • Unquestionable ethics, professional integrity, and personal values consistent with the values 

  • BS degree in a relevant scientific discipline.  Advanced degree is preferred (MS/PhD/PharmD) 
  • 6-9 years industry experience, with at least 6-9years working in regulatory affairs (regionally or globally). 
  • Delivery of  a number of  major applications (NDA/BLA/IND,  etc…) 
  • Experience with late stage development/marketed  products 
  • Prior  experience in the rare disease/rare blood disorders therapeutic area 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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