Product Development Manager

• Conduct market research and analysis to
  identify new product opportunities and evaluate market trends
  

·         Knowledge of state, federal, and international regulatory
requirements and submissions (Federal marketing application such as DCGI, NDA
(New drug Application), ANA, IND (Investigational New Drug), PMA, etc…) for
Pharmaceutical (or medical device) products.

·         Ensure compliance with all relevant regulatory requirements and
guidelines, including FDA (Food and Drug Administration) and other global
regulatory agencies

• Manage the entire product development
  process from concept to launch, ensuring products are developed on time,
  within budget, and to quality standards
  
• Develop and manage project plans, timelines,
  and budgets for multiple projects simultaneously
  
• Lead cross -functional teams in
  problem -solving and decision -making to ensure the timely resolution of
  issues that arise during the product development process
  
• Work closely with the marketing team to
  develop product positioning, messaging, and launch plans
  
• Manage and develop a team of product
  development professionals, providing guidance, coaching, and mentorship as
  needed
  

Qualifications include:

• Education: B Pharm / M Pharm / MBA -Marketing
  or related field degree. Advanced technical degree is preferred
  
• Minimum of 7+ years’ relevant pharmaceutical
  industry experience with a portion of that experience in product
  development of sterile injectable drugs produced by aseptic processes.
  
• Strong knowledge of regulatory requirements
  and guidelines, including DCGI, FDA, EMA, and other global regulatory
  agencies
  
• Familiar with Chemistry, Engineering and
  Manufacturing operations.
  
• Strong leadership skills, with the ability to
  motivate and develop a team of product development professionals