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