Urgent Requirement For Regulatory Affairs Manager

Key Responsibilities:

€¢ Strategic Leadership: Develop and implement regulatory strategies for new and existing products, ensuring alignment with company objectives and global regulatory requirements.

€¢ Submission Management: Prepare, review, and submit high-quality regulatory dossiers to regulatory agencies (., FDA, EMA) for product registrations, variations, and renewals.

€¢ Compliance Assurance: Monitor and interpret evolving regulations, guidelines, and standards to ensure ongoing compliance and proactively address potential risks.

€¢ Collaboration & Communication: Collaborate effectively with cross-functional teams (R&D, Quality, Manufacturing) to provide regulatory guidance and support throughout the product lifecycle.

Requirements:

€¢ Regulatory Expertise: In-depth knowledge of global pharmaceutical regulations, guidelines, and standards (., ICH, GMP).

€¢ Strategic Thinking: Ability to develop and implement effective regulatory strategies aligned with business objectives.

€¢ Communication & Collaboration: Excellent written and verbal communication skills with the ability to build strong relationships with internal and external stakeholders.

€¢ Problem-Solving & Decision-Making: Analytical and problem-solving skills with the ability to make sound decisions in a complex regulatory environment.

€¢ Leadership & Management: Proven ability to lead and motivate a team, providing guidance and support to achieve departmental goals.

Education Required :

€¢ Proven experience as a Regulatory Affairs Manager in the pharmaceutical industry.

€¢ Strong understanding of drug development and manufacturing processes.

€¢ Excellent knowledge of regulatory submission requirements and procedures

• Experience

  9 - 12 Years

• No. of Openings

  1

• Education

  Graduate (B.Sc)

• Role

  Manager Regulatory Affairs

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office