Manager - Global Labelling Regulatory Affairs

1 week ago

Bengaluru, Karnataka, India Biocon Full time

Biocon Biologics is at the forefront of the healthcare industry revolution, placing patient needs above all else. Our goal is to positively impact the lives of billions by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. As a diverse global company, our employees are driven by purpose and passion to collaborate closely with partners and patients worldwide, committed to delivering high-quality, affordable biosimilars.

With expertise spanning from clone development to commercialization in various markets, we are proud to lead the biosimilars market revolution. One of our key departments, Global Regulatory Affairs, plays a crucial role in ensuring successful global submissions and approvals, navigating the complex regulatory landscapes of different countries.


Global Regulatory Affairs:

  • The Global Regulatory Affairs (GRA) team at Biocon is made up of talented individuals who serve as the bridge between the company and regulatory agencies internationally.
  • The GRA group is instrumental in devising a robust regulatory strategy based on robust scientific, technical, and regulatory foundations.
  • Understanding the unique regulatory guidelines and procedures of each country can be challenging, especially for complex molecules in an ever-evolving regulatory environment.
  • Thanks to our dedicated team and strong regulatory expertise, we have achieved several milestones, including being the first to file and obtain approval for biosimilar products in multiple countries.
  • Our pipeline of biosimilars covers various therapeutic areas and is a testament to our commitment to making a difference in healthcare.

Key Responsibilities:

  • Develop a labeling strategy for health authority interactions and handle labeling queries efficiently.
  • Manage artwork for submissions and commercial launch activities.
  • Review promotional materials to ensure regulatory compliance.
  • Coordinate with external vendors for translation support.
  • Prepare SPLs and manage labeling changes effectively.
  • Analyze competitor information for regulatory projects.
  • Collaborate with stakeholders to address labeling submission issues.
  • Maintain documentation and manage global labeling impact assessments.
  • Lead and mentor the labeling team to maintain quality standards.

Minimum Qualifications and Experience:
Pharmacy / M.Pharmacy

  • At least 10-15 years of experience in Global Labeling.
Preferred Qualifications/ Skills.

  • Strong organizational skills and time management abilities.
  • Proactive approach to identifying label issues and developing negotiation strategies.
  • In-depth knowledge of quality and compliance standards.
  • Effective communication and problem-solving skills.
  • Ability to mentor junior staff and adapt to changing priorities.
  • Capability to handle multiple priorities and achieve business objectives.

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