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Regulatory Manager - India
Dupont Biosciences (company)
Posted on : 10 April 2017
- Since medical packaging is a regulated industry, the goal is to understand the regulations and requirements that must be met by customers, sterile packaging manufacturers (SPMs), medical device manufacturers (MDMs), by pharmaceutical companies and healthcare facilities as well as they do.
- Using this knowledge the incumbent shall identify and leverage issues, opportunities and activities that create market pull by raising brand awareness and increasing influence with key stakeholders as a preferred material of choice in Medical and Pharmaceutical Protection.
Regulatory & Standards Manager Responsibilities:
- Responsible for the regulatory & standards strategy for MPP in India and supporting R&S activities.
- Responsible for effective relationship management with Targeted Regulators, Professional Influencers and Thought Leaders in the broader industry and its stakeholders
- Participation & Leadership in targeted standard setting organizations, in particular with Bureau of Indian Standardization (BIS)
- Participation & Leadership in targeted industry associations
- Support the demand creation through influence and education with key government agencies and influential industry associations for medical device and pharma manufacturers as well as hospitals in India.
- Support and provide training to local DPS organizations in identified AP regional countries on regulatory topics, strategy and key activities for local regulatory engagements.
- Develop a regulatory map & knowledge base to identify key regulatory issues, stakeholders, activities and events for India and AP regional countries
- Establish key milestones and measurements of success for regulatory influence work streams and ensure the progress is on track.
- Support other functions (such as quality, technical) to provide regional regulatory guidance
- Support the MPP SPM account management process
- Support the MPP MDM outreach and key account management processes
- Support the MPP Healthcare Outreach& Thought Leadership Initiatives
- 8 - 10 years of experience in dealing with medical and/or pharmaceutical regulatory issues.
- Experience in the development of standards is an asset.
- Knowledge of sterilization and packaging standards is an asset
- Ability to collaborate, generate influence and to demonstrate leadership both within and outside of our company , across functions, networks, customers, regulators and other stake holders.
- Strong communication & presentations skills in English.
- Multi- cultural experience is essential to be able to deal with various cultures globally