Regulatory Submission Professional Job in Chennai at Pfizer

Pfizer is hiring for the role of Regulatory Submission Professional!

Responsibilities:

• Contribute to the completion of project milestones and organize own work to meet project task deadlines.
• Provide regulatory insight & strategies to cross-function teams as regulatory liaisons throughout the product lifecycle.
• Prepare, submit, coordinate, and follow up on product registrations to ensure timely approval according to the product registration plan and handle any amendments to registered products.
• Provide regulatory affairs-related information to other divisions and coordinate regulatory activities between divisions, Business Units, Corporate Affairs, Quality Operations, etc.
• Assist Regulatory Affairs team lead to establish, develop, and maintain close working relationships with the relevant regulatory authorities and associations.
• Follow necessary approval procedures in updating Local Product Documents as per local regulatory requirements and Pfizer's Standard Operating Procedures (SOPs).
• Ensure that registered products are maintained and updated in full compliance with all relevant legislation and SOPs and ensure compliance with other relevant company SOPs.
• Responsible for the periodic review of all documents and procedures, ensuring the required due dates are consistently met preserving document integrity.
• Provide supporting documents for the government/Hospital Authority tender applications.
• Maintain relevant registration licenses, regulatory affairs-related information/ system, correspondence, and other relevant documentation for easy retrieval.

Requirements:

• Bachelor's Degree
• Proven ability to speak to large groups of people to provide system and process flow training
• Maintains familiarity with company product ranges and ensures compliance with regulations
• Robust knowledge of electronic repositories and document management systems
• Good interpersonal, communication, and negotiation skills
• Fluency in written and spoken English
• Excellent computer skills in Microsoft Office Suite, Adobe Acrobat, etc
• Experience in CTA (Clinical Trial Application)
• Demonstrated experience in the Pharmaceutical industry
• Prior knowledge of local regulatory environment and regulations
• Knowledge of effective training methods