Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
Post: Regional Head - Regulatory Affairs(GM /Sr GM) Emerging Markets
Job Description:
Areas of Responsibility
The incumbent will support for Company's and 3P product registration in the emerging markets ensuring that all the approvals are acquired and maintained. This role is multi-regional (across emerging markets) and has people management and project resourcing responsibilities.
He / She will support for managing the execution of the strategy for Market Applications and post-market supplements/variations for Emerging Markets including African continent, Middle-East/South East Asia, Russia, Ukraine & other CIS Countries, Brazil, Latin America.
Providing guidance on regional regulatory mechanisms to optimize product registration including expertise on regional regulatory requirements and precedence to cross functional teams
Planning and managing regulatory submissions (e.g. marketing applications) for products in compliance with global filing plans and local regulatory requirements
With guidance implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
Managing the development of the regional product label by collaboration to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
Supporting regional label negotiation activities
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Masters Degree in Pharmacy preferred with 15 - 20 years of experience.
Regulatory knowledge in regional legislation
Experience with product filing and life cycle management experience across emerging markets and be able to execute product strategy
Knowledge of and experience in regional regulatory environment in relevant product area and development stage
Additional Information:
Experience: 15-20 Years
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 16th Aug, 2013
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