Regulatory Affairs Specialist generating regulatory submissions and managing compliance for medical device engineering projects at Teleflex. Ensuring adherence to FDA and Health Canada regulations with effective project timelines.
About the role
- Director Regulatory Affairs overseeing global regulatory activities and clinical submissions for Oncology products. Requires extensive experience in pharmaceutical regulations and leadership in project teams.
Responsibilities
- provide leadership on global regulatory activities for assigned products
- focus on clinical regulatory filings
- provide regulatory leadership on project teams
- supply, lead and/or supervise IND/CTA and BLA submissions
- interpret regulatory authorities’ feedback, policies, and guidelines
- develop regulatory strategic plans with project teams
- own preparation of major clinical submissions for regulatory approval
- resolve complex project issues
- ensure quality and timeliness of IND/CTA and BLA submissions
- interact with functions and partners in preparation, review, and completion of documents
- assure compliance with regulations and project team timelines
- provide interpersonal support and lead personnel
- critical thinking, strong negotiation and project management skills
Requirements
- MD, Ph.D. or Pharm D. degree
- minimum of 10 years of pharmaceutical industry experience
- at least 7 years of regulatory experience
- strong understanding of US FDA and international pharmaceutical guidance
- ability to coordinate and prioritize assigned projects according to company goals
- interacting with CROs in managing ex-US/ex-EU CTAs towards clinical trial activations preferred
- strong interpersonal skills both written and verbally
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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