Senior Manager - Regulatory Affairs Job in Gurgaon at Lilly

Lilly is hiring for the role of Senior Manager - Regulatory Affairs!

Responsibilities of the Candidate:

• Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements.
• Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables.
• Preparation and support of new applications to obtain marketing authorisations.
• Voicing affiliate perspective and needs to global and regional regulatory contacts.
• Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
• Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports)
• Maintain Regulatory Tools in alignment with defined compliance metrics.
• Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans.
• Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions
• Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.
• Facilitate interactions with regulatory bodies on a regular basis.
  Regulatory Compliance
• Ensure that internal Regulatory IT tools are up to date and accurate.
• Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
• Ensure that the regulatory archive is complete and up-to-date and that all current licenses and labels are readily available.
• Ensure implementation of local quality system in line with the global quality system and local regulations.
• Support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.

Requirements:

• Bachelor's degree or equivalent in a relevant scientific subject
• At least one year industry-related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs.
• Team working skills with special focus on results.
• Ability to adapt to challenging situations.
• Demonstrated good computer/IT skills.
• Good knowledge of written and spoken English.
• Analytical, problem-solving solving and negotiation skills.
• Good communication skills.
• Project management skills.
• Strong planning and priority setting.
• Good capability to establish positive networking both internally and externally.
• Strong knowledge of quality systems.