Job Position: Manager – Regulatory Conformance
Job Location: Chennai, India
Description:
We’re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
Job Summary
- Committed to quality and excellence in compliance and conformance
Accountable for maintaining the corporate change and dossier management system (PDM) regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies. - Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.
Job Responsibilities for Manager – Regulatory Conformance at Pfizer
- Committed to quality and excellence in compliance and conformance
- Accountable for maintaining the corporate change and dossier management system (PDM) regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies.
- Ensures timely communication of any issues e.g. Board of Health queries to the regional teams as needed
- Manages multiple regions/projects/timelines of moderate complexity within a Work Team.
- Manages workload within the team for business continuity
- Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.
- Responsible for evaluation of all CMC notifications for accuracy.
- Responsible for making updates in PDM Market Views for all submission types upon receipt of notification of Submission and Approval evidence
- Applies technical knowledge and key concepts in PDM Conformance updates. Considered as a technical resource within the work team.
- Demonstrates strong technical/functional knowledge w.r.t Regulatory requirements and internal process to coach direct reports on day-to-day activities
- Breadth of technical/functional expertise is focused on applicable discipline
- Acts as a mentor for the colleagues
- Actively shares knowledge with others within Work Team through existing knowledge sharing processes/systems.
- Solves moderately complex problems within area of expertise
- Demonstrates effective written and oral communication skills
- Support for updates in PDM for License withdrawals
- Operate to the highest conformance and quality standards
- Operate in line with internal SOPs and policies
- Encourages the participation and perspectives of all Work Team’s members
- Supports developmental and training opportunities for mentees
- Adhere to standard turnaround timelines
- Escalate any potential compliance issues to management
- Liaise with regulatory colleagues to communicate and resolve potential issues
- Provide input to continuously improve and streamline the process
- Support periodic and ad-hoc system reports to estimate metrics
- Contribute to local and regional regulatory initiatives promoting a culture aligned with
- Pfizer values and which supports compliance, innovation and talent development and retention
- Assist in ensuring internal regulatory processes and procedures are well documented
- Assist in remediation activities
Technical Skills –
- Knowledge and / or experience in Pharmaceutical industry in Regulatory / Quality
- Assurance, especially in Life cycle management or compliance.
- Strong quality and compliance orientation
- Diligence and attention to detail
- Prior Regulatory experience in any of the market
- Knowledge of regulatory practices, rules, regulations and guidelines
- Good communication skills
- Problem Solving
- Understanding stakeholder needs
- Fluent English Speaker
- Standards, Processes and Policies – General standards, processes and policies of
- Pfizer/Pharmaceutical manufacturing
Behavioral /Any other Skills – An assertive, take-charge, results oriented, positive “can do” attitude, and a sense of urgency doing things done.
Qualification we seek in you for Manager – Regulatory Conformance at Pfizer !
- Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
- Preferred Year Of Experience – 10 to 14 years of experience in a quality or compliance role within the pharmaceutical industry
- Type of Experience – Demonstrated regulatory or quality experience within a pharmaceutical company with proven examples of contribution. Proven ability to consistently deliver to high quality standards and timelines. Proven ability to successfully operate in a cross functional environment
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Possible interview questions may be asked for Manager – Regulatory Conformance at Pfizer
- Question: Can you discuss your experience in regulatory compliance within the pharmaceutical industry, especially in relation to quality assurance and life cycle management?
Answer: Certainly. I have over 10 years of experience in regulatory compliance roles within the pharmaceutical industry. My background includes managing quality assurance processes and life cycle management for regulatory submissions. I have been involved in ensuring adherence to regulations, guidelines, and internal quality standards to maintain product excellence and compliance.
- Question: How have you demonstrated your ability to maintain high-quality standards and timelines in your previous roles?
Answer: In my previous roles, I have consistently adhered to strict quality standards and timelines by effectively coordinating cross-functional teams, streamlining processes, and closely monitoring regulatory requirements. By proactively identifying potential bottlenecks and addressing compliance issues, I have ensured that regulatory submissions are accurate, timely, and compliant with relevant regulations.
- Question: Can you provide an example of a complex problem you’ve encountered in a regulatory context and how you addressed it?
Answer: Certainly. In a previous role, our team faced a challenge with a regulatory submission that required significant data consolidation and review. To address this, I implemented a structured review process, assigned specific responsibilities to team members, and leveraged technology to streamline data compilation. This approach improved collaboration, reduced errors, and led to the successful submission ahead of the deadline.
- Question: How do you ensure effective communication and collaboration within cross-functional teams to ensure compliance and deliver efficiencies in the regulatory submission process?
Answer: Effective communication is key to successful regulatory compliance. I ensure clear communication by establishing regular team meetings, providing concise updates on submission progress, and addressing any questions or concerns promptly. I encourage open dialogue and create a collaborative environment where team members feel comfortable sharing insights and raising potential issues.
- Question: Can you discuss your experience with change and dossier management systems (PDM) in maintaining regulatory CMC submissions with global health authorities?
Answer: In my previous roles, I have actively managed corporate change and dossier management systems (PDM) to track the status of regulatory CMC submissions. I have ensured that information is accurately updated in line with internal SOPs and policies. This involves timely communication of issues, accurate record keeping, and collaborating with regional teams to address queries effectively.
