- 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
1) Technical Skills -
- Theoretical 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
2) Standards, Processes and Policies - General standards, processes and policies of Pfizer 3)
3) Behavioral/Any other Skills – An assertive, results oriented, positive “can do” attitude, and Time management skills.
4) Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
5) Preferred Year Of Experience - 2 to 4 years of experience
6) Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferable.
Nice-to-Have
- Project Management experience
- Knowledge across multiple therapeutic areas
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.
Regulatory Affairs
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