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OTC Regulatory Affairs Manager

OTC Regulatory Affairs Manager

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OTC Regulatory Affairs Manager

  • Location:


  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:


  • Job type:


  • Contact email:

  • Job ref:


  • Published:

    13 days ago

  • Duration:

    12 Months +

  • Startdate:


Global professional services company need a Senior strategic OTC Regulatory Affairs manager to manage Health Authority approvals for their clients pharmaceutical portfolio. This role involves guiding regulatory strategy, overseeing submissions, and maintaining critical dossier information. Specifically, we need someone experienced in supporting OTC switch submissions in the USA and potentially Europe at a later stage.

The assignment will be 12 months, with the likelihood of an extension.


  • Define global regulatory strategies, with a focus on OTC switches in the USA market.
  • Collaborate with stakeholders to meet technical requirements and regional regulatory standards.
  • Proactively manage regulatory information and identify and mitigate risks.
  • Deliver electronic and paper regulatory submissions in compliance with national market standards.
  • Act as the single point of contact for clients and participate in governance meetings.
  • Qualifications: Minimum Qualifications:
  • Bachelor's degree in science or related field.
  • Extensive global regulatory affairs and operations experience.
  • Proven success in compiling and filing end-to-end regulatory submissions.
  • Deep understanding of OTC regulations in the USA (and EU) markets.
  • Experience managing regulatory teams and providing strategic guidance.
  • Excellent communication and interpersonal skills.
  • Ability to generate innovative solutions and adapt to changing priorities.
  • Skilled in fostering customer relationships and collaboration.

Minimum qualifications:

  • Bachelor's degree in science or related field.
  • Extensive global regulatory affairs and operations experience.
  • Proven success in end-to-end regulatory submissions and Marketing Authorisations.
  • Expertise in OTC switches and deep knowledge of USA and EU OTC regulations.
  • Regulatory experience in pharmaceuticals, vaccines, or biological products.
  • Effective management of regulatory teams, including strategy, training, and client communication.
  • Superior multicultural communication skills, both oral and written.
  • Innovative problem-solving and collaboration with stakeholders.
  • Strong leadership, interpersonal, and negotiating skills.

The role will be fully remote and for any candidates within the UK, the role will be inside IR35.

Please call me or send suitable resumes and I will respond immediately