Selecta Biosciences
  • Watertown, MA, USA
  • Salary
  • Full Time

 VP/ SVP Regulatory Affairs  

 NO PHONE CALLS OR AGENCIES PLEASE

 Overview

Reporting to the CEO, in this newly created position, the Vice President of Regulatory Affairs will be responsible for all aspects of Regulatory Affairs related to clinical developmentCMC and commercialization. The Vice President of Regulatory Affairs will lead the strategic direction and operational aspects of global regulatory compliance and submissions for all projects across the company. Position will be responsible for developing the strategic plan for obtaining approval for compounds in the pipeline and for developing strong relationships with the FDA and other global regulatory agencies.  The candidate will also be responsible for building the appropriate sized internal support and managing the external support to implement and execute the strategic plan to ensure rapid and timely approvals that will lead to the achievement of Selecta's business objectives.

 Principal Duties/Responsibilities 

  • Formulate, create and implement a regulatory strategy and related activities needed to secure approvals
  • Develop and implement strategies for timely submission and approval of regulatory submissions from IND through BLA
  • Ensure regulatory compliance of marketed and investigational drugs with the FDA and other applicable regulatory jurisdictions (e.g. EMA)
  • Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications
  • Monitor the regulatory process to ensure company compliance with all regulatory commitments, obligations and interactions
  • Manage the compilation, submission and maintenance of INDs, BLA's and amendments
  • Actively participate on project teams providing regulatory strategy, guidance and compliance oversight for Selecta's product candidates
  • Identify and assess regulatory risks for assigned projects or programs

Qualifications

  • Bachelor's Degree in a scientific discipline required
  • Advanced degree preferred (MS/PhD/PharmD)
  • 15+ years of industry experience, with at least 10 years working in regulatory affairs (regionally and/or globally)
  • Regulatory experience with biologics including delivery of major applications (such as BLA/MAA) and securing approval
  • Experience with early/mid/late stage development and marketed products

Knowledge, Skills and Other Experience

  • 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 regulatory policy and guidance
  • Substantial experience in representing the sponsor and interfacing and negotiating with regulatory authorities (e.g. FDA, EMA)  
  • Demonstrated leadership ability as well as ability to be a team player and work well within cross-functional teams
  • Ability to motivate and lead others
  • Excellent oral communication and writing skills,
  • Change management/change enabler, and embraces the challenges of a fast changing environment
  • Generates innovative solutions in work situations, trying different and novel ways to address work challenges and opportunities
  • Excellent operational skills
  • Unquestionable ethics, professional integrity, and personal values consistent with the Selecta Biosciences values
  • Travel: Up to 25% of the time, including international travel

Qualified candidates should apply online at www.selectabio.com/careers.

About Selecta Biosciences, Inc.

Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP) to a range of biologics for rare and serious diseases that require new treatment options. The company's current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company's lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's SEL-403 product candidate, a combination therapy consisting of SVP-Rapamycin and LMB-100, recently entered a Phase 1 trial in 2018 for the treatment of patients with malignant pleural or peritoneal mesothelioma. Selecta's proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP also holds potential in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.

 Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).

 

Full Job Description
Selecta Biosciences
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