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Senior Regulatory Compliance Expert

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Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to serve as an expert individual contributor within our organization. This role requires comprehensive knowledge of regulatory affairs, with the ability to manage and execute highly complex or specialized projects. The Specialist will apply advanced regulatory expertise, adapting precedents and developing innovative approaches to ensure compliance and successful product approvals.

Key Responsibilities

  • Lead the development and preparation of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
  • Act as the primary liaison with regulatory agencies to expedite approval of pending registrations and maintain compliance throughout the product lifecycle.
  • Provide regulatory guidance during product planning and implementation, regulatory strategy development, risk management, and chemistry manufacturing control (CMC) activities.
  • Ensure timely approval of new drugs, biologics, or medical devices, as well as continued approval of marketed products.
  • Represent the regulatory function in cross-functional teams, including marketing, research, and technical groups.
  • Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory requirements.
  • Interpret and apply regulatory guidelines to business and product decisions, ensuring alignment with organizational and compliance initiatives.

Requirements

  • Degree in Pharmacy, Life Sciences, Biotechnology, or a related field (Masters).
  • Minimum 7 years of experience in Regulatory Affairs, preferably in pharmaceuticals, biologics, or medical devices.
  • Demonstrated expertise in regulatory submissions, interactions with regulatory agencies, and lifecycle management.
  • Strong knowledge of global regulatory frameworks and requirements.

Desirable Skills and Competencies

  • Excellent understanding of regulatory guidelines and processes.
  • Strong project management and problem-solving skills.
  • Effective communication and stakeholder management abilities.
  • Ability to work independently as a subject matter expert and contribute to cross-functional teams.

Benefits

  • Competitive compensation package.
  • Opportunity to work with a leading organization in the industry.
  • Collaborative and dynamic work environment.