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Director, Regulatory Affairs – Immunology

Posted about 1 month ago

  • Sector: Pharmaceutical
  • Contact: Jorge Rios
  • Contact Email: j.rios@sciproglobal.com
  • Contact Phone: 424-644-6170
  • Expiry Date: 30 July 2021

Essential Duties & Responsibilities:

· In support of clinical and commercial products, develop, prioritize, execute, and provide guidance for effective regulatory strategies and plans

· Collaborative regulatory lead for project teams and sub-teams, effectively contributing to team regulatory submissions and business deliverables

· Work effectively with Team on post-approval supplements, change control and necessary regulatory filings to support commercial products and post-marketing commitments

· Ensure submissions to regulatory health authorities are complete, well-organized, of high quality, working in concert with subject matter experts, external vendors and with Regulatory Operations

· Perform and manage effective and timely regulatory intelligence and research, in support of regulatory affairs team

· Monitor current and evolving regulatory guidance, provide risk assessments and recommendations for various regulatory scenarios

· Manage the regulatory aspects of promotional materials, as well as sales training materials and medical communications, publications

· Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact the Company’s promotion of products and operations – Advise personnel in other departments regarding their applicability and impact

· Interface with other team leaders to ensure coordination and implementation of consistent standards and processes

· Ensure quality submissions, including proofreading documents and working closely with Regulatory Operations to publish the final regulatory submissions

· Provide appropriate promotional compliance and regulatory training and guidance to sales reps and medical science liaisons regarding their respective roles and responsibilities


Requirements:

· 10 years of experience in biopharmaceutical industry or equivalent, with a minimum of 5 years in Regulatory Affairs. Experience

· Experience in Biosimilars preferred

· Bachelors degree; advanced degree preferred

· Must be able to search retrieve interpret and apply regulations

· Experience in establishing and managing regulatory intelligence through search evaluation and distillation of regulatory and oncology clinical data sources

· Experience and a understanding of promotional material requirements

· Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills

· Exceptional cross-functional team leadership skills, and ability to work in close collaboration with other

· Strong organizational and planning skills for self and others, and strong attention to detail

· Accountable for results and goal attainment

· Experience with electronic submissions requirements and the review of promotional materials prepared in support of regulatory filings

· Ability to work independently with limited supervision, adapt to change and manage multiple tasks

· Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting

· Technical knowledge of US regulations and ICH Guidelines

Location:

  • Fulltime, based in Redwood City

Compensation & Benefits:

  • Base salary up to $225K

  • Bonus target - 20%

  • Stock Options