Pfizer Life Sciences Associate Job Opening, Apply Online
Pfizer Life Sciences Associate Job Opening, Apply Online. Pfizer is hiring candidates for an Associate I – Regulatory Conformance vacancy. Interested and eligible applicants can check out all of the details on the same below –
Hey there, looking for some insight into what types of interview questions can be asked for an Associate I – Regulatory Conformance role at Pfizer? Then check them out below
Job Title – Associate I – Regulatory Conformance
Job ID – 4884681
Location of Pfizer Vacancy – India – Chennai
Why Patients Need You
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 regulato
ry 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 in compliance and conformance
- Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
- Manages the day to day work by self with periodic supervision by the Lead/Designee
JOB RESPONSIBILITIES
- Committed to quality and excellence in compliance and conformance
- With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned.
- Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
- Contributes independently and manages own time to meet the timelines.
- Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
- Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
- Makes informed decisions on straight cases within guidelines and policies
- Support for updates in system for License withdrawals
- Operate in line with internal SOPs and policies
- Adhere to standard turnaround timelines
- Escalate any potential compliance issues to management
- Support periodic and ad-hoc system reports to estimate metrics
- Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
- Assist in ensuring internal regulatory processes and procedures are well documented
- Assist in remediation activities
- Support the teams in ADHOC activities
- Shares the learning time to time with the team colleagues
QUALIFICATIONS / SKILLS
Technical Skills –
- Theorotical Knowledge on Regulatory Affairs / Compliance
- Experienced in Regulatory / Quality Assurance/ Production or any other functions in Pharmaceutical or related industries.
- Diligence and attention to detail
- Good communication skills
- Understanding stakeholder needs
Standards, Processes and Policies – General standards, processes and policies of Pfizer
Behavioural/Any other Skills – An assertive, results oriented, positive “can do” attitude, and Time management skills.
Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
Preferred Year Of Experience – 2 to 4 years of experience
Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferrable.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Hey there, looking for some insight into what types of interview questions can be asked for an Associate I – Regulatory Conformance role at Pfizer? Then check them out below
- Can you explain your understanding of regulatory affairs and compliance in the pharmaceutical industry? How have you applied this knowledge in your previous roles?
- Answer: Regulatory affairs and compliance involve ensuring adherence to local and global regulations in the development, approval, and post-marketing of pharmaceutical products. I have actively stayed updated with regulatory guidelines, performed assessments, and contributed to maintaining compliance in my previous roles. For example, I have conducted regulatory evaluations of notifications, maintained the Health Authority (HA) status in corporate change and dossier management systems, and collaborated with colleagues to identify and address gaps in regulatory compliance.
- How do you ensure accuracy and attention to detail in your work, particularly when managing complex cases or discrepancies?
- Answer: Accuracy and attention to detail are crucial in regulatory conformance. When dealing with complex cases or discrepancies, I consult with my team lead or designated authority for clarification and guidance. I verify information, review relevant guidelines and policies, and make informed decisions within the given framework. I prioritize thoroughness and conduct comprehensive checks before updating systems to ensure accuracy and regulatory compliance.
- Can you provide an example of a time when you had to meet tight timelines and deliver high-quality work? How did you manage the situation?
- Answer: In my previous role, there was a time-sensitive project where regulatory submissions had to be prepared within a short timeframe. To manage the situation, I carefully planned the workflow, allocated tasks efficiently, and communicated clear expectations to the team. I closely monitored progress, addressed any obstacles promptly, and ensured timely completion of deliverables while maintaining quality standards. Effective time management, coordination, and proactive problem-solving were key factors in successfully meeting the tight deadlines.
- How do you stay updated with the evolving regulatory environment and incorporate changes into your work?
- Answer: Staying updated with regulatory changes is essential for maintaining compliance. I regularly engage in continuous learning through various channels such as attending industry conferences, participating in webinars, subscribing to regulatory newsletters, and networking with professionals in the field. I also proactively review regulatory guidelines, assess their impact on our operations, and collaborate with colleagues to implement necessary changes. By staying informed and adaptable, I ensure that our processes align with the latest regulatory requirements.
- How do you approach working collaboratively with colleagues and stakeholders to address compliance gaps or potential issues?
- Answer: Collaboration is key in addressing compliance gaps and potential issues. I actively engage with colleagues and stakeholders, promoting open communication and knowledge sharing. I encourage regular meetings to discuss challenges, analyze data, and identify areas for improvement. By fostering a collaborative environment, I ensure that compliance concerns are addressed collectively, leveraging the expertise and insights of team members. I value stakeholder perspectives and actively seek their input to develop effective strategies for maintaining regulatory conformance.
Remember, these sample answers can serve as a reference point. It’s important to personalize your responses based on your own experiences and qualifications during the interview.
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