Manager/Sr Manager - Regulatory Affairs - Pharma

- Good knowledge of regulatory pathways and options/strategy for India in particular and Europe and Rest of the World

- Knowledge and experience of preparing Common Technical Documents and Clinical Trial Application dossier

- Should prepare position papers for internal presentation to Management and Task force committee - strategy for registering the product in different markets, pros and cons, information on product related competitors in similar markets, licensing requirements and end to end understanding of regulatory procedures for registering a product in India, Europe and Rest of the world

- Be able to manage the changes during the life cycle of the product

- Should have understanding of GMP, GDP & GLPs

- Knowledge of preparing eCTD (electronic Commercial Technical Documents)

- Main focus will be on the development and execution of regulatory strategy for the assigned components of regulatory applications and submissions

- Managing and coordinating various regulatory activities throughout the life cycle of the project/product

- Additional focus will be on appropriate planning for prioritization and coordination of activities among functional areas and within Regulatory affairs, and for timely identification and communication of project/product related concerns to the Head- RA such that same can be addressed in a timely manner

- The position is expected to organise and lead contacts with regulatory agencies and/or parent company

- Should have excellent oral and written communication skills and presentation skills

- Be able to manage small teams of 2-3 people

Qualification: Masters in Biological Science (Immunology/ Microbiology/ Virology/ Bacteriology) or Masters in Pharmacy

Experience: Total 10-12 yrs in pharma injectables out of which at least 7 yrs of regulatory affairs experience

Call at 9849006750

Ravi Kumar
Director