Job Description

Business:

Piramal Critical Care

Department:

Regulatory Affairs

Location:

Kurla

Travel:

Low

Job Overview

The Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities, country distributors or external partners. Will work closely and train other junior regulatory staff.

Key Stakeholders: Internal

External partners, Country Distributors, Health Authorities

Key Stakeholders: External

Cross-Functional Teams

Reporting Structure

Reports to: Senior General Manager-Regulatory Affairs
Direct Reports: Yes

Essential Qualification & Experience

Master's in Pharmacy degree, full time (Regulatory Affairs certification is preferred) Minimum of 8 to 10 years' of experience in a pharmaceutical regulatory affairs department.

Experience in leading dossier submission to Latam/ ROW markets and post approval variations.

Key Responsibilities

Work closely with internal and external manufacturing sites to. assess post approval product chemistry, manufacturing and control (CMC) changes and determine appropriate global filing strategy Manage the assembly, compilation, submission and electronic publishing (if required) of documentation for product compliance, registration and life cycle maintenance. Support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, product development and review, and other strategic deliverables. Evaluate business opportunities and perform regulatory due diligence for in licensing and product acquisition for assigned region. Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include ICH, WHO, GMP, USP, stability, validation, and US regulations. Review and interpret pertinent regulations and guidelines to develop proactive solutions to regulatory issues and challenges and communicate them to the other team members and functionalities within the organisation

Competencies

Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders Expert knowledge and proficiency at interpreting regulatory guidelines. Possess excellent abilities to draft the CMC section of dossier Strong analytical, conceptual, problem-solving, and decision-making abilities Effective collaboration skills Proactive, with a strong ability to learn and adapt Advanced skills in Microsoft Office Suite (Excel, Word, PowerPoint, and Access) Critical Thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems Proficient in both verbal and written communication Ensuring the maintenance of confidentiality at all times Capable of presenting multiple solutions creatively Displaying enthusiasm and a positive attitude * Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers