Associate Manager I - Reg CMC Strategy, Vaccines Job in Chennai at Pfizer

Pfizer is hiring Associate Manager I - Reg CMC Strategy, Vaccines

Responsibilities of Candidate:

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Provide input to the relevant stakeholders for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans {e.g., business development or manufacturing supply) & alignment is achieved between regulatory activities and relevant country business/commercial plans.
• Support Regulatory Affairs group development and maintain internal regulatory databases, tracking and document management systems.
• Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
• Review technical supportive information for submission to support change.
• Ensure compliance and consistency of product labels with local requirements.
• Represent the regulatory team at cross-functional team meetings, where required.
• Escalate any issues or concerns within the functional line and/or relevant leadership for adjudication.
• Ensure assigned projects of manufacturing/packaging site are approved on agreed timeline and closely communicate with site/Logistics to ensure smooth of supply.
• Oversee and manage the completion of clinical trial applications.
• Supports Query and commitment management in collaboration relevant stakeholders.
• Maintain licenses in compliance with local regulations by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place, and that staff are trained in these systems and procedures.

Requirements:

• Bachelor's Degree
• 3+ years of demonstrated experience in regulatory affairs or in a regulated industry
• Proven ability to manage complex regulatory issues and consistently deliver to time and quality standards
• In-depth knowledge of the current health regulatory framework for drug regulatory procedures
• Problem solving skills, strong detail, quality and compliance orientation
• Good verbal and written communication skills and fluent in English
• Proficient computer skills, e.g. MS Office, MS Outlook, Internet, database use