Job Description
Key Responsibilities:
- Ensure quality and excellence in compliance and conformance.
- Evaluate notifications assigned with a reasonable understanding of regional regulations.
- Maintain HA status in corporate change and dossier management systems.
- Manage time independently to meet timelines.
- Collaborate with GRA colleagues to identify and escalate gaps.
- Perform accurate updates in the system for most cases and consult with Team Lead/Designee for complex cases.
- Make informed decisions within guidelines and policies.
- Support updates in the system for license withdrawals.
- Operate in line with internal SOPs and policies.
- Adhere to standard turnaround timelines.
- Escalate potential compliance issues to management.
- Support periodic and ad-hoc system reports to estimate metrics.
- Contribute to local and regional regulatory initiatives aligned with Pfizer values.
- Assist in ensuring internal regulatory processes and procedures are well documented.
- Assist in remediation activities.
- Support teams in ADHOC activities.
- Share learning with team colleagues.
Technical Skills:
- Theoretical knowledge of Regulatory Affairs/Compliance.
- Experience in Regulatory/Quality Assurance/Production or other functions in the pharmaceutical or related industries.
- Attention to detail and diligence.
- Good communication skills.
- Understanding stakeholder needs.
Candidate Profile:
- Standards, processes, and policies knowledge of Pfizer.
- Assertive, results-oriented, positive attitude, and time management skills.
- Preferred qualifications: Master’s/Bachelor’s degree in Chemistry, Pharmacy, or related life sciences.
- Preferred experience: 2 to 4 years in the pharmaceutical or relevant industry, preferably in regulatory, quality, or compliance roles.
Additional Information:
- Experience: 2 to 4 years
- Qualification: Master’s/Bachelor’s degree or equivalent
- Location: Chennai
- Industry Type: Pharma/Healthcare/Clinical research
- Functional Area: Regulatory
- End Date: 20th August 2024