Head Of Regulatory Affairs

Position: Manager/ Senior Manager (Head) - Regulatory Affairs 

Location: Bangalore

Desired Profile:

• Degree in Life Science or related discipline required. Higher degree preferred (PharmD, M. Pharm, MSc, PhD, MBA).
• 10+ Experience in developing and delivering global regulatory strategies for product development and approval
• Working experience IND and NDA filing of NCE products at global regulatory stage would be preferred

Job Description, Key Skills and Competencies:

• The candidate will represent the company with domestic and international regulatory authorities and business partners.
• The candidate will be responsible for formulating global regulatory strategy for all the projects and will present it to relevant internal and external stakeholders.
• The candidate will identify and assess regulatory risks associated with product filing. The candidate will define strategies to mitigate the risks.
• The candidate will provide regulatory guidance to company personnel throughout the research and development process.
• The candidate will set strategic direction and lead global regulatory submission process, including NOC & test license, marketing applications and core briefing packages.
• The candidate will advise on global CTA / IND submission strategy.
• The candidate will monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
• The candidate will work closely with cross functional teams to prepare IND/NDA dossiers and regulatory response. 

Competencies:

• Understanding of various regulatory requirements for new drug development
• Presentation & Communication Skills
• Team Management
• Interpersonal Skills
• Stakeholder Management