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This position brings strategic regulatory leadership to North America pipeline projects in the OTC drug, device, cosmetic, food or dietary supplement areas, with an emphasis on US OTC Monographs. Consumer focused, this position is expected to incorporate marketplace, technology and regulatory ...

Job Description

This position brings strategic regulatory leadership to North America pipeline projects in the OTC drug, device, cosmetic, food or dietary supplement areas, with an emphasis on US OTC Monographs. Consumer focused, this position is expected to incorporate marketplace, technology and regulatory trends into well-crafted regulatory strategies. Builds strong relationships with all stakeholders, internal and external.

Role Responsibilities

Strategy:

  • Provide regulatory leadership to NA cross functional project teams, pertaining to OTC Monograph Drug product development and launch, and business development opportunities.
  • Interacts and works collaboratively with multidisciplinary North American and global teams, ensuring regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success.
  • Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts within the region.
  • Uses internal and external networks to ensure regulatory strategies are robust and keep pace with dynamic regulatory environment

Execution:

  • Partner with project teams to ensure required regulatory contributions meet business needs and are provided to the project teams to agreed time and quality standards.
  • Ensures that an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the regional business are championed and communicated.
  • Regulatory review and approval of launch advertising and promotional copy.
  • Lead development of regulated labeling content for new products

External Engagement:

  • Interpret and understand government regulations and industry code of conduct.
  • Monitor, analyze and advise the business on existing and emerging regulatory trends and requirements.
  • Engages in appropriate activities to influence the regulatory environment through other PFE colleagues, Agency contacts and/or Trade associations (as appropriate).

Qualifications

Basic qualifications

  • Scientific bachelor or advanced degree required
  • Minimum of 3-5 years experience in Rx or OTC Regulatory Affairs, consumer products experience preferred

Preferred Qualifications

  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.
  • Demonstrate the ability to research and analyze information and develop regulatory strategies.
  • Demonstrate the ability to work independently and within a group setting, and to interact effectively with various functional groups.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • Able to strategically influence and negotiate with internal and external customers
  • A high level of attention to detail.