Pharmacy & Chemistry Regulatory Specialist Vacancy @ GSK – Apply

Pharmacy & Chemistry Regulatory Specialist Vacancy @ GSK – Apply

GSK Regulatory Specialist job opening 2022. Chemistry job opening 2022. Pharmacy job vacancy 2022. Chemistry and pharma job. MSc Chemistry job opening. M Pharma job opening 2022. Chemistry specialist job opening 2022. Interested and eligible candidates may check out all the details on the same below:

Job Title:  Regulatory Specialist- License Maintenance

Location: Bengaluru Luxor North Tower

Id: Bengaluru Luxor North Tower

Eligibility Criteria:

Minimum Level of Education – Bachelor’s degree

Area of Specialization – Chemistry, pharmacy or other related science or technical bachelor’s degree.

Job Purpose

• Responsible for the GRC regulatory delivery activities (e.g., Variations <CMC &
• Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>, Annual Reports, Facilities Variations) of assigned projects with minimal input from line manager.
  Supports Global Regulatory by producing appropriate components for global regulatory dossiers with minimal input from line manager.
• Has training responsibilities for new staff on established departmental processes.

Key Responsibilities

• With minimal input from the manager, executes agreed dossier strategy
• With minimal input from the manager, manages multiple project assignments (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>, Annual Reports, Facilities Variations) simultaneously; dossiers will range in complexity
• With minimal input from the manager, complete data assessment to ensure dossier is fit for purpose.
• With minimal input from the manager, identifies risks associated with the submission of data and information packages.
• Communicates with line manager to identify issues that have business impact.
• May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies, and systems.
• Developing an understanding of regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
• Understands internal/external regulatory environment.
• Actively builds an organizational network.
• Communicates across GSK, with minimal input from manager regarding project and policy issues ensuring the optimum position for GSK.

Apply Online

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