Work as Manager - Regulatory Affairs in Pfizer India

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

Job Description:
Position Purpose
The PCO based Manager, Regulatory Affairs will be responsible for managing and controlling the Regulatory activities related to Innovative products and locally manufactured products (Pfizer Global Manufacturing), Generic products including line extensions and Consumer Healthcare products. Responsible for all regulatory and labeling compliance for Pfizer marketed products. Responsible for interaction with regulatory authorities to obtain licenses, maintenance of license. Should be able to recommend efficient strategies. Manages and provides strategic directions oversight to country based regulatory team members.

Organizational Relationships:
• Direct Report to Director, Regulatory Affairs

Resources Managed (budget and FTEs):
• Supervision (Position reporting directly to the incumbent): Associate, Regulatory Strategy & Operations.

Primary Duties:
• Lead the local RA team members in the development of regulatory strategies to support the registration new products, generic products, line extensions, major variations and lifecycle management. Ensure that local RA teams provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives
• Develop strong partnerships with in-country (e.g. Medical, Marketing, Supply Chain) and Therapeutic Area and Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization
• Ensure stakeholders in India are updated on Regulatory Strategy and Operations thus providing optimal support for meeting business objectives.
• Develop and enhance the capabilities and capacities of Associate, Regulatory Strategy & Operations through the identification and implementation of training and development needs.
• Generate and meet customer expectations on regulatory support and deliverables.
• Development of artworks and labels are per requirement of Drugs and Cosmetic Act and Rules in coordination with medical team
• To provide support to the Institutional Business and Export Business with required documents e.g., Performance Certificate, No Objection Certificate, No Conviction Certificate, Manufacturing / Marketing Certificate, Free Sale Certificate etc.
• Prepare new application for the submission for the renewals of GMP/WHO GMP/CPP (CPPs) for all Manufacturing site and for the products manufactured at those site for Pfizer business.

Find More Info Go Next Page...

Subscribe to Pharmatutor Job Alerts by Email

• Procure Test Licence for new product development/line extensions (SKUs’).
• Prepare applications for the timely submission to obtain/renew Sales License
• Maintain and prepare the application for the renewal of the In-house R&D recognition for Thane plant
• Provide document support for registration and renewals of registrations for India business
• Co-ordinate with the relevant customers (internal/external) for trigger/support to regulatory issues arising out of PGM product manufacturing, and Consumer Healthcare products.
• Co-ordinate with the Regulatory liaison group to follow up for obtaining/renewal/cancellation of manufacturing licenses and additional product permissions.
• Maintain the systems and processes related to regulatory business
• Maintain databases of the regulatory status and other pertinent details related to PGM, Consumer HC Products.
• Responsible for maintaining all regulatory documentation (licenses, certificates, etc) related to PGM in compliance with country regulations and applicable Pfizer procedures
• Will be responsible for maintaining all regulatory documentation in compliance with country regulations and applicable Pfizer Procedures for India and India Region (as required)
• Will maintain databases of regulatory status and other pertinent details for all Pfizer, Pharmacia, Wyeth products and upkeep of Indian data on the Global Regulatory System (GRS) database.
• Will oversee all local labeling activities per local and global SOPs and regulations.
• Implement regular regulatory communication to PGM / BVO stakeholders through regular through proper channels.
• Will be responsible for assuring maintenance of approval status for all locally manufactured products, including proactive suggestion of strategies when appropriate, and measures for regulatory safeguarding and defense of locally manufactured products for India and India Region, if required.

Candidate Profile:
Training & Education Preferred:
• A graduate or post-graduate degree in Biological Sciences, Pharmacy, Pharmacology or any other relevant discipline.
• Should have 5-8 years experience in Regulatory Affairs in the Pharmaceutical industry.

Prior Experience Preferred
• Proven ability to consistently deliver to time, cost and quality standards.
• General management experience and previous line management and leadership experience at senior management level is essential
• Demonstrable experience of effective delivery in a complex matrix environment.
• Knowledge of manufacturing related to Indian regulatory laws and guidelines
• Knowledge of quality systems and processes pertaining to GMP (Good   Manufacturing Practices)
• Knowledge of Artwork and labeling related to Regulatory and Pharmacopoeial       requirements.
• Knowledge of different Forms to be used for application for grant of Mfg.license.
• Knowledge of different schedules of D & C act particularly Schedules C,C1,G,H and M
• Technical medical terminology and its usage
• Knowledge of developments in regulatory affairs worldwide
• Simultaneous, multiple project handling capacity.

Technical Competencies:
• Knowledge of the 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

Behavioral (Core) Competencies:
• Understanding stakeholder needs
• Network and alliance building/ peer relationships
• Influencing
• Team working
• Interpersonal acumen
• Organizational agility
• Perspective
• Strong quality and compliance orientation
• Analytical Thinking
• Leadership and Management
• Adaptability

Additional Information:
Experience: 5-8 Years
Location: Mumbai
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: DRA
Job ID: 974203