Biocon - General Manager - Regulatory Affairs Formulations - US Market

Key Responsibilities :

- To work as a Single Point of Contact (SPOC) between partners at US and the company with respect to all Regulatory submissions and discussions.

- Closely work with partners and Setting up of the meetings with the Agency

- Facilitate all Regulatory submissions with the Agency through partners.

- Build a good rapport with the Agency and employees from the partner company

- Attend all teleconference meetings with partners for addressing any deficiencies, discuss the status of pending dossiers and pending supplements, etc.,

- Active participation in the preparation of Module-1 of dossier (country specific) and to fulfil any other US specific requirement

- Basic knowledge on Pharmacovigilance i.e. adverse event reporting to US agency.

- Should represent the company in important conferences/workshop in the region and - should play an influential role in drafting the local regulations.

- Should be able to work closely with the Regulatory team based out of India for technical and administrative deliverables in the region.

- Understand importance of regulatory updates and communications and transfer all such information efficiently to internal relevant team members

Technical Skills and Expertise :

- Should have minimum 15 years of hands on experience specifically in US market

- Expertise in US registration having registered at least 25 Dossiers successfully

- In depth knowledge on regulatory requirements including post approval changes In US

- Capable of anticipating potential queries and also should be well versed in Risk mitigation - Good understanding about global regulations like ICH, USFDA, Canada, Europe etc.

- Excellent communication skill

- Technical and managerial skills to understand and guide cross functional teams

- Experience and Expertise to develop country specific regulatory strategy

- Experience in working with regulatory consultants

- Experience in preparing change notifications and convincing partners and Agency.

- Good negotiation skill and develop good rapport with the Agency

- Excellent Leadership skills

Experience & Qualification :

- Should have minimum 12 years of hands on experience specifically in US market

- PhD/M. Pharma/MSc/M. Tech

- Management and Customer Service experience Strong administrative skills

- Demonstrated ability to lead

- Strong communications & leadership skills