Regulatory Affairs Manager

8 hours ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Regulatory Affairs Manager - Submission Publishing Job Description

Job Summary:

We are seeking a highly skilled Regulatory Affairs Manager to lead our submission publishing efforts. As a key member of our team, you will be responsible for delivering high-quality submissions while ensuring compliance with global health authority requirements.

Key Responsibilities:

Team Leadership & Operations:

  • Lead and mentor a team of submission publishers.
  • Manage workload vs. resource allocation to ensure optimal team productivity and efficiency.
  • Oversee the publishing workflow to ensure timely and compliant submission delivery.

Regulatory Submission Management:

  • Ensure submission quality by resolving publishing challenges and guiding the team in troubleshooting.
  • Drive a First-Time-Right approach by educating the team on regulatory and publishing requirements.
  • Monitor regulatory requirements across regions and ensure team adaptation and compliance.

Collaboration & Stakeholder Management:

  • Collaborate with Regulatory Affairs, Affiliates, and Regional Leads to resolve submission gaps and drive alignment.
  • Participate in eCTD kick-off meetings and contribute to discussions around implementation in new markets.

Training & Development:

  • Conduct Train-the-Trainer programs and ensure end-user training for publishing systems.
  • Serve as Subject Matter Expert (SME) across pharma and vaccine product lines.

Technical Competencies & Expertise:

  • Strong expertise in eCTD concepts, publishing standards, and troubleshooting.
  • Hands-on experience with publishing tools; ability to identify white spaces and suggest improvements.

Requirements:

  • Proven track record of leading successful teams in regulatory affairs.
  • Excellent communication and stakeholder management skills.
  • Ability to work effectively in a fast-paced environment.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

What We Offer:

  • A challenging and rewarding role in a growing industry.
  • The opportunity to work with a talented team of professionals.
  • A comprehensive benefits package, including medical, dental, and vision coverage.

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