Regulatory Affairs Manager

1 month ago

Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at 1925 GlaxoSmithKline LLC. As a key member of our regulatory affairs team, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.

Key Responsibilities
  • Develop and implement CMC regulatory strategies to support product development and lifecycle management.
  • Manage global CMC regulatory activities, including preparation and submission of regulatory documents, and coordination with cross-functional teams.
  • Provide regulatory guidance and support to teams, including interpretation of global guidelines, procedures, and policies.
  • Identify and mitigate risks associated with submission data and information packages.
  • Lead CMC Subject Matter Expert activities and engage with external stakeholders to shape the regulatory environment.
  • Develop and maintain relationships with regulatory agencies and industry bodies.
  • Provide strategic direction and data assessment to support business decisions.
Requirements
  • Bachelor's degree in a relevant field.
  • 6+ years of experience in regulatory affairs, with a focus on CMC.
  • Strong knowledge of drug development and manufacturing processes.
  • Excellent communication and negotiation skills.
  • Ability to work independently and as part of a team.
Preferred Qualifications
  • Master's degree or PhD in a relevant field.
  • Experience in pharmaceutical industry or research organizations.
  • Knowledge of camlipixant development history and regulatory submissions.
  • Leadership experience and ability to motivate and lead others.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

We are an equal opportunity employer and adhere to affirmative action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.

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