Associate I - Regulatory Conformance

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

4910549