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Job as Manager, Regulatory Affairs at Pfizer

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Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post:  Manager, Regulatory Affairs

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Role Description   
 Job Purpose

The PCO based Manager will provide regulatory support/ inputs for country business for successful launch of new products & portfolio expansion. The PCO based  Manager would work to ensure collaborative connectivity with the key stakeholders (e.g. Commercial, Medical,  above  country colleagues  etc.),   and  share a focused regulatory approach to supporting country business objectives.    The person  would support   India as well as the clusters supported  from India PCO (i.e. Nepal, Sri Lanka, Bhutan & Bangladesh) 

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Position Responsibilities
• Delivery on compliance in assuring and fulfilling the regulatory performances in India and the  India cluster markets.
• Provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives and in the development of regulatory strategies to support the registration of new products, line extensions, major variations and lifecycle management. 
• Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, etc.).  Act in the capacity as the liaison and contact for local government regulators with regards to all regulatory affairs related activities.
• Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders.  Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies and decision making.  Positively influence local legislative initiatives that could impact the business.
• Approval and maintenance of all license and no adverse business impact due to lack of regulatory approvals. 
• Demonstrate and promote Pfizer global value system across all interactions.
• Contribute to Pfizer’s quality-consciousness and research-based image
• Generate and meet customer expectations on regulatory support and deliverables
• Implement technology solutions for enabling better information availability.

Organization Relationships
Internal interactions:
• Interactions  with  key  stakeholders : In country (Commercial, Medical, PGS  etc.), above  country colleagues (Product strategist, country strategist, the  GCMC  hubs,  Labeling Hubs , ALIM hub etc.) External interactions
• India : Interaction with    HA / BOH   
• India  cluster : The  Distributors

Resources Managed
Supervision - One  direct  report ( contingent worker )

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Knowledge / Skills / Experience 
Technical Skills Knowledge of the India, Regional and Global regulatory environment and how this impacts regulatory strategy and implementation. Knowledge of drug development practice, rules, regulations and guidelines. Strategic Thinker
Communication skills
Negotiation skills
Problem Solving
Understands Business and Financial Environment
Understands Pharmaceutical Industry 

Qualifications
• Scientific Degree.  A higher degree (M. Pharm) may be an advantage but is not essential.
• Pharmacist degree preferred  but  not  mandatory .
• Appropriate Regulatory Experience – minimum 4-5 years experience.
• Management Degree (Undergraduate or MBA) may be an advantage.
• Knowledge of pharmaceutical affairs regulations and regulatory process and environment
• Negotiating, communication, interpersonal and presentation skills
• Familiarity with relevant Global/Local SOPs desirable
• Fluency in written and spoken English 

The candidate is required to have a clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment. Change agility is also an essential attribute. 

IN LINE WITH GOOD DEVELOPMENT PLANNING , IT IS RECOMMENDED  THAT COLLEAGUES DISCUSS THEIR SUITABILITY AND/OR READINESS FOR A NEW POSITION AND THEIR DIRECT MANAGER PRIOR TO APPLICATION. COLLEAGUES ARE REQUIRED TO INFORM THEIR MANAGER IF INVITED TO INTERVIEW FOR THE POSITION.  

Job ID:     1032368     
Location:     India-Mumbai                   
Last Date : 6th, June, 2016     

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