- Conduct market research and analysis to identify new product opportunities and evaluate market trends
Knowledge of state federal and international regulatoryrequirements and submissions (Federal marketing application such as DCGI NDA(New drug Application) ANA IND (Investigational New Drug) PMA etc) forPharmaceutical (or medical device) products.
Ensure compliance with all relevant regulatory requirements andguidelines including FDA (Food and Drug Administration) and other globalregulatory 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 crossfunctional teams in problemsolving and decisionmaking 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 / MBAMarketing 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 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
Salary 1012 LPA
Required Experience:
Manager