Senior Operations Director

2 weeks ago


Dholka, Gujarat, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000
Job Title : Senior General Manager

A strategic leadership role in which the incumbent will be responsible for ensuring that all regulatory requirements are met while driving business growth.

Key Responsibilities :
  • Establish and maintain relationships with regulatory authorities, government bodies, and international customers to ensure compliance and achieve business objectives.
  • Provide technical guidance to cross-functional departments on regulatory submissions, including preparation of scientifically sound documentation within committed project timelines.
  • Develop and implement strategies for regulatory submissions during business development discussions with international customers and the International Marketing Division.
  • Guide the regulatory/quality team to perform their respective functions efficiently and accurately by identifying team members' capabilities and assigning additional responsibilities accordingly.
  • Facilitate compliance with Good Manufacturing Practices (GMP) audit observations for own facilities.
  • Collaborate with cross-functional departments to implement systems for regulatory expectations and compliance.
  • Review and provide guidance on technical and investigation reports to ensure adherence to regulatory guidelines and provide input to cross-functional technical teams for the requirement and content of regulatory documentation.
Requirements :
  • Strategic thinking and planning skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a matrix environment.
  • Strong analytical and problem-solving skills.
  • Knowledge of regulatory requirements and industry standards.


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