GSK Hiring B.Pharm / M.Pharm Candidates for Regulatory Job
Regulatory Associate Job for B.Pharm / M.Pharm Candidates At GSK. GSK Hiring B.Pharm / M.Pharm Candidates for Regulatory associate manager Position at multiple locations. Interested Candidates check out the details below and Apply Online
Job title: Regulatory associate manager-I/ II / III-CTA/IND Development delivery
Job Location: Bengaluru, India; Worli Mumbai, India
Job id: 379842
Job Category: Regulatory
Job Type: Full Time
Job description
RoleÂ
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.
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
Basic Qualifications:
- Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience (consult manager on equivalent regulatory experience)
- 1+ years’ experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience
Preferred Qualifications:
- 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
GSK Hiring B.Pharm / M.Pharm Candidates for Regulatory associate manager Position. Here are five interview questions and sample answers :
1. Question: Can you describe your experience in handling Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance?
Answer: In my previous role as a Regulatory Associate Manager, I had the responsibility of overseeing CMC regulatory activities for both new product registrations and life-cycle maintenance. This involved preparing and submitting sections of registration files, variations, renewals, and responses to Regulatory Agency inquiries. I ensured that all documents and dossiers were of high quality and met regulatory compliance standards. Additionally, I collaborated closely with colleagues in various global functions and Regulatory Affairs to prioritize and deliver submissions in a timely manner.
2. Question: How do you stay up-to-date with evolving regulatory requirements and guidelines in the pharmaceutical industry, and how do you apply this knowledge to your work?
Answer: Staying current with regulatory requirements is crucial in the pharmaceutical field. I make it a point to regularly review and monitor updates from regulatory agencies and industry organizations. I also participate in relevant training programs and workshops to enhance my understanding. When new guidelines or regulations are introduced, I work with cross-functional teams to assess their impact on our regulatory strategies and ensure that we remain compliant. Continuous learning and adaptation are key to my approach.
3. Question: Can you provide an example of a situation where you had to interact with colleagues from different functions and Regulatory Affairs to deliver a high-quality regulatory submission? How did you ensure technical congruency and regulatory compliance?
Answer: Certainly. In a recent project, we were preparing a submission that required collaboration across multiple functions, including Quality Assurance, Manufacturing, and Regulatory Affairs. To ensure technical congruency and regulatory compliance, I initiated regular cross-functional meetings. During these meetings, we discussed each department’s contributions and aligned our efforts to meet the submission requirements. This proactive approach helped us identify potential challenges early, resolve them efficiently, and deliver a high-quality submission on time.
4. Question: How do you handle situations where there are potential changes in regulatory requirements, and how do you ensure timely compliance and documentation?
Answer: When there are potential changes in regulatory requirements, I first conduct a thorough analysis to understand the implications for our ongoing projects. I communicate these potential changes to relevant stakeholders and initiate discussions to determine the best course of action. This may involve adjusting our regulatory strategies, updating submission documents, or implementing new procedures. Throughout the process, I maintain meticulous documentation to track changes, compliance efforts, and outcomes, ensuring that we meet all regulatory obligations.
5. Question: Regulatory compliance is critical in the pharmaceutical industry. Can you share your approach to ensuring compliance standards and key performance indicators (KPIs) are consistently met in your role?
Answer: Maintaining regulatory compliance is a top priority in my role. I establish clear communication channels with cross-functional teams to ensure everyone is aware of compliance requirements and KPIs. I regularly monitor progress against these standards and proactively identify areas that may require attention or improvement. Additionally, I conduct periodic internal audits to assess our compliance status and address any non-compliance issues promptly. By fostering a culture of compliance and accountability, I ensure that regulatory standards and KPIs are consistently met.
These sample questions and answers should help you prepare for an interview for the Regulatory Associate Manager position in CTA/IND Development delivery. Customize your responses based on your specific experiences and qualifications.
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