R&D Regulatory Specialist

3 days ago

Durham, United States Connexion Systems & Engineering, Inc. Full time
Job DescriptionJob Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

R&D Regulatory Specialist (Remote / PT)

Notes:

  • 100% remote, anywhere in the US.
  • Part-time – 20 hours+/- per week.
  • Needs a flexible schedule to accommodate various departments & regulatory agencies.
  • Devising regulatory strategies and leading cross-functional teams from beginning to end for regulatory submissions are essential.
  • The ideal candidate will have regulatory experience in a pharma setting with FDA and EU submissions.
  • Candidate should have a good sense of regulatory strategy and working with Regulatory Operations for various types of submissions.
  • Experience working with in a cross-functional team and cross-cultural team as well.
  • This role requires a minimum of a Bachelor's degree.
  • Onboarding: Standard BG. 10 panel drug screen (THC not a disqualifier).


Description:

  • Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals.
  • Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products.
  • Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements.


Job Duties:

  • Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products
  • Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.
  • Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.
  • Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.
  • Advises Management on regulatory aspects of product development and/or lifecycle management.
  • Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
  • Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
  • Writes documents with complex scientific information for regulatory submissions.


Job Requirements:

  • Bachelor's Degree in a related scientific discipline with at least 4+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry.
  • Knowledge and understanding of FDA and EU regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations.
  • Excellent oral and written communication skills. Critical thinking and problem-solving skills.
  • Demonstrated project management skills.
  • Ability to interact with regulatory officials.
  • Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
  • Ability to work within a global team framework and multi-cultural environment.
  • Ability to write comprehensive scientific information for use in regulatory submissions to the FDA and EU.
  • Ability to manage multiple complex projects and timelines in a matrix team environment.
  • Demonstrated interpersonal skills including negotiation.
  • Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines.
  • Leadership skills within a matrix driven organization.

 

Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

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