Associate II -Reg Strategy, Brands Job in Chennai at Pfizer

Pfizer is hiring for the role of Associate!

Responsibilities of a Candidate:

• Manage individual projects of benefit to therapeutic area teams within the group
• Day-to-day provision of general assistance to Strategists in the compilation of regulatory dossiers, coordination of marketing applications, and responding to regulatory questions received from health authorities, as well as compilations of responses to queries that can serve multiple purposes.
• Support for the use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed.
• Author and Maintain Regulatory Product profile documents by updating as requested by the strategist when key milestones occur. Including status of product indications supplement status per AG settlement
• Generate Pearl reports, WWRS reports, etc, in support of Renewals, launches, and health authority queries on a need basis.
• Author and QC electronic applications, cover letters, and submission packages as requested by the Strategist in support of the life cycle maintenance of products.
• Support registration of new products by Dossier QC, CCS QC, gap analysis, anticipated health authority query tracker, and coordination between stakeholders.

Requirements:

• Education: Postgraduate in Pharmacy or Science. 2 to 6 years of experience preferred
• Skills Required – Excellent written, listening, and verbal communication skills, ability to problem solve, technical aptitude ability to quickly learn and use new software, regulations and quality standards, attention to detail, ability to work independently with appropriate level of supervision, experience in customer service environment, aptitude in project management and logistics
• Preferred – knowledge of regulatory processes and documents, knowledge of therapeutic areas