Title:  Head Regulatory Affairs (India)

Reporting to: Sr. Vice President - Regulatory Affairs

Qualification:  Master’s Degree in Pharmacy, PhD in  Pharmacology or Pharmaceutics (desirable).

Experience:  10+ years                                                       

Location:  Baroda / Mumbai.                                     

Responsibilities:

• Work with various cross-functional teams within the organization to ensure that availability of a development, execution and submission pathway for submission of products for India market ensuring first time approval/first mover advantage.
• Develop optimum regulatory pathway for product approval to ensure competitive advantage for new drugs/FDC/devices/neutraceuticals etc.
• Participate and provide regulatory guidance to development and other teams during the development to ensure right data is generated and presented in the submission.
• Provide regulatory guidance for protocol design for clinical studies that are cost efficient and productive.
• Participate in SEC and other related discussions to represent regulatory view point.
• Support manufacturing plants during inspections.
• Provide support to life cycle management and business continuity for current products such as transfers.
• Work with CROs/CMOs to support out sourcing by providing regulatory inputs.
• Ensure procurement and renewal of Licenses of all locations for the outsourced products.
• Ensure regulatory compliances at Company’s warehouses and godowns.
• Work with IP commission, NIB, Central and State Laboratories for company related issues.
• Draft and submit appropriate justifications and representation to State and Zonal offices Central HQ in cases of NSQ issues reported in monthly drug alert.

Technical Skills

• Thorough understanding of applicable rules and regulations including Indian Drugs & Cosmetics Act, Medical Device, NDCT Rules, Nutraceutical and other regulations.
• Regulatory understanding of licensing requirements as applicable for development and commercialization of products in India.
• Familiarity of Indian systems impacting regulatory workflows.
• Familiarity with licensing authorities in India including CDSCO.
• Understanding of different pharmaceutical dosage forms.

Personal Skills

• Negotiation skills.
• Communication & presentation – written and verbal.
• Attention to detail.
• Willingness to challenge the status quo and ask questions.
• Curiosity.
• The ability to listen and learn.
• Able to view issues from a holistic perspective.
• Passionate and proactive.
• Time management.
• Problem solving.
• Ability to work in large teams and lead a team.