GSK Hiring Pharma Graduates for the role of Associate Manager III.
Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you. GSK hiring Pharma graduates for the role of Associate Manager III.Apply online.
Job Description: As Regulatory Affairs Management Professional you will be responsible for the execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.
Location: Worli Mumbai, India.
- Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience (consult manager on equivalent regulatory experience)
- 7+ years’ experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience
- Knowledge of regulatory submissions to markets
- Ability to ensure compliance standards and key performance indicators are met
- Regulatory expertise in knowledge of the regulatory life cycle
- Ability to interact at many levels
- Technical knowledge
Roles and Responsibilities:
- Responsible for chemistry, manufacturing and controls of regulatory matters relating to registrations and/or maintenance of business activities
- Prepare sections of registration files, briefing books, clinical trials applications, chemistry, manufacturing and controls variations, renewals files, and responses to Regulatory Agency questions,
- Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents and materials to local Regulatory Affairs in accordance with business priorities
- Ensure close partnership with authors, assuring technical congruency and regulatory compliance
- Apply system and procedure updates to maintain proper records and support adequate controls
- Provide evaluations for potential changes as requested and follow up to ensure regulatory compliance and completion of appropriate internal compliance records
- Effectively communicate regulatory requirements and guidelines, facilitating timely and complete submissions
- Develop up-to-date knowledge to guidelines and regulatory requirements, as well as technical trends
Possible Interview Questions and Answers:
- Question: Can you describe your experience with regulatory submissions to various markets?
Answer: In my previous roles, I have been responsible for preparing and submitting regulatory documents for multiple markets, including [mention specific markets or regions]. This involved understanding the unique requirements and regulations of each market and ensuring compliance with them.
- Question: How do you ensure that compliance standards and key performance indicators are met in your regulatory work?
Answer: To ensure compliance and meet key performance indicators, I establish clear processes and timelines for regulatory activities. I regularly review these processes, track progress, and conduct internal audits to identify and address any compliance issues promptly.
- Question: Can you explain your understanding of the regulatory life cycle and its significance in regulatory affairs?
Answer: The regulatory life cycle encompasses the entire journey of a product, from development to post-market maintenance. It involves initial registrations, variations, renewals, and continuous compliance. Understanding this cycle is crucial for maintaining product approvals and ensuring business continuity.
- Question: How do you interact with colleagues in other global functions and Regulatory Affairs to deliver high-quality regulatory dossiers and documents?
Answer: I believe in cross-functional collaboration. I regularly engage with colleagues from different departments and global teams, coordinating efforts to compile high-quality regulatory documents. Effective communication and a clear understanding of roles and responsibilities are key to successful collaboration.
- Question: What technical knowledge and skills do you possess that are relevant to regulatory affairs?
Answer: My technical knowledge includes [mention specific technical areas relevant to the role, e.g., pharmaceutical manufacturing processes, quality control, analytical methods]. These skills are essential for assessing and ensuring the technical congruency of regulatory documents.
- Question: Describe your approach to preparing sections of registration files and responses to Regulatory Agency questions.
Answer: I follow a systematic approach, starting with a comprehensive review of regulatory requirements. I gather all necessary data and information, ensure accuracy, and create well-structured documents that address the agency’s questions or requirements effectively, with a strong focus on clarity and completeness.
- Question: How do you stay up-to-date with changing regulatory guidelines and technical trends in your field?
Answer: Staying current in the regulatory field is vital. I regularly attend industry conferences, subscribe to regulatory news updates, and participate in training programs. Additionally, I actively engage in industry associations and networks to exchange knowledge and insights.
- Question: Can you provide an example of a challenging regulatory issue you’ve encountered and how you resolved it?
Answer: In a previous role, we faced a complex change in manufacturing processes that required regulatory approval. I led a cross-functional team, collaborated closely with experts, and prepared a comprehensive submission package that addressed potential concerns. We successfully obtained regulatory approval, ensuring business continuity.
- Question: How do you prioritize tasks and manage multiple regulatory projects simultaneously?
Answer: Prioritization is key in regulatory affairs. I use project management techniques to establish clear priorities based on business impact, deadlines, and regulatory requirements. This allows me to allocate resources effectively and ensure that all projects progress as planned.
- Question: Can you explain the importance of maintaining proper records and supporting adequate controls in regulatory affairs?
Answer: Proper record-keeping is essential for demonstrating compliance with regulatory requirements. It also supports transparency and traceability in case of audits or inquiries. I maintain detailed records of all regulatory activities, ensuring that they are readily available for review and audit purposes. This practice helps uphold regulatory standards and business integrity.