Regulatory Affairs Expert

2 weeks ago

Gurgaon, Haryana, India IPL Biologicals Limited Full time

Job Title: Sr. Manager/Manager Regulatory Affairs

Job Summary: IPL Biologicals Limited is seeking a highly skilled and experienced Sr. Manager/Manager Regulatory Affairs professional to lead our regulatory affairs team. The successful candidate will have a strong understanding of regulatory guidelines and requirements, exceptional leadership and strategic planning skills, as well as the ability to work effectively in a fast-paced and dynamic environment.

Key Responsibilities:

  • Develop and implement regulatory strategies and plans to support the development, registration, and commercialization of biological products in various global markets.
  • Ensure that regulatory submissions, including but not limited to INDs, BLAs, and post-approval submissions, are in compliance with relevant regulations and are of the highest quality.
  • Serve as the primary point of contact for regulatory agencies and lead interactions, meetings, and negotiations with regulatory authorities.
  • Keep abreast of changes in regulatory requirements and guidelines and advise internal teams on potential implications and necessary actions.
  • Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, quality, and commercial teams, to ensure alignment with regulatory requirements and expectations.
  • Conduct regulatory assessments and gap analyses to identify potential issues and develop risk mitigation plans.
  • Collaborate with internal and external stakeholders to ensure that regulatory milestones and objectives are met on time and within budget.
  • Manage and mentor a team of regulatory affairs professionals, providing leadership, guidance, and support to ensure high performance and professional growth.

Requirements:

  • A minimum of 8 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on biological products.
  • Strong understanding of regulatory requirements and guidelines, including FDA and EMA regulations.
  • Proven track record of successful regulatory submissions and interactions with regulatory agencies.
  • Excellent communication, leadership, and project management skills.
  • Ability to work effectively in a cross-functional team environment and influence decision-making.

About Us: IPL Biologicals Limited is a leading biopharmaceutical company dedicated to developing and commercializing innovative biological products. We are committed to delivering high-quality products and services that meet the needs of our customers and stakeholders. If you are a dedicated and experienced regulatory affairs professional looking to make a difference in the biopharmaceutical industry, we encourage you to apply for this exciting opportunity.

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