Senior Manager - Regulatory Affairs

Role: Senior Manager - Regulatory Affairs

Reporting to: Senior Director - Pharmaceutical Development

Location: Hyderabad

Experience: At least 14 years of industrial experience, in the field of regulatory affairs for India and other markets

Qualification: M. Pharma/ Masters in Pharmaceutical Regulatory Affairs or Equivalent from a reputed University.

Purpose of the Role: Regulatory support for new product development & registration for LBOE India and Global LCM portfolio. Driving and monitoring activities in line with local and global regulatory requirements, while working with internal and external partners

Job Description:

• Carry out dossier compilation, writing of CTD and related documents required for submission of marketing authorization application in India to achieve marketing authorization approval.

  
  

• Support & ensure developing appropriate regulatory strategies in consultation with internal /external experts and regulatory authorities to achieve first cycle approval of products.

  
  

• Carryout & support compilation of IMPD, briefing package and CTD dossier for pIND, IND and scientific advisory meetings to achieve Clinical study approvals and product development strategy.  

  
  

• Ensure handling and responding queries to regulatory authorities to achieve Timely approval of products.

  
  

• Carry out and ensure timely submission of dossier to drug authority and ensuring that approvals are obtained within scheduled time to achieve timely completion of projects in line with the requirements.

  
  

• Support Guiding on clinical strategy, providing input on clinical study protocol and report to achieve clinical study approvals and product development strategy.  

  
  

• Carry out & support development of in house regulatory scientific skills and appraise team on change in regulatory guidance to achieve in house skill development on regulatory.

  
  

• Carry out gap analysis and risk assessment for the submission based on the available data/documents and mitigation plan to achieve First cycle approval of products.

  
  

• Carry out & support dossiers compilation and submission for BE NOC application, Form-29, CDSCO NOCs, import permission etc. to Facilitate product development.

  
  

• Support review and approve protocols, reports, validation plans, development report, DMFs, CEPs and other CMC documents to achieve Compliance to regulatory requirements.

  
  

• Support new product development with special attention to fit- for-purpose regulatory requirements to Facilitate product development.

  
  

• Support new product development with special attention to fit- for-purpose regulatory requirements Facilitate product development.

  
  

Required Competencies
• Good level of Project handling skills with internal & external partners.
• Familiar in GxP
• Proven ability to manage, lead and motivate people
• Fluent in English and excellent communication skills
• Proactive and team oriented