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Post: Manager, Regulatory Affairs
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)
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 )
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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