Biocon - General Manager - Regulatory Affairs Formulations - US Market (12-20 yrs)
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