Associate I

3 weeks ago

Chennai, India Pfizer Full time

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 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 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.

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