Senior Regulatory Affairs Leader

2 weeks ago


Trenton, New Jersey, United States Atlas Search Full time

About the Role

Atlas Search is collaborating with a prominent biopharmaceutical organization in search of a skilled Senior Regulatory Affairs Leader. This position presents a remarkable chance to shape global regulatory frameworks for their cutting-edge pharmaceutical offerings.

The annual base salary for this role is positioned between $140,000 and $170,000, with actual remuneration influenced by a variety of factors.

Key Responsibilities:

  • Serve as a strategic consultant to regulatory bodies and work alongside regional regulatory teams for US initiatives.
  • Oversee the work of regulatory consultants and external partners as required.
  • Provide regulatory insights and support across all divisions within the organization.
  • Conduct comprehensive analyses of regulatory trends and competitive landscape.
  • Identify potential compliance gaps and propose innovative solutions to mitigate risks.
  • Ensure that development activities align with industry regulations and standards.
  • Assist in strategizing and executing interactions with global health authorities and submissions.
  • Lead significant submissions and responses to regulatory agencies.
  • Accurately interpret and relay communications from health authorities.

Qualifications:

  • Advanced degree (Masters, PharmD, PhD, MD) is preferred.
  • Experience in Oncology or Rare Diseases is a plus.
  • A minimum of 3 years of regulatory experience within the industry is required.


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