Associate I – Regulatory Conformance

2-4 years

Not Disclosed

Chennai

10 Aug. 7, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Why Patients Need You

At Pfizer, we are committed to expediting the delivery of medicines and vaccines without compromising on excellence and integrity. Navigating the complex and evolving regulatory landscape is crucial to expanding patient access to our products. Your expertise and dedication will help ensure compliance with local and global regulations, enabling us to bring our innovations to patients more swiftly and safely.

What You Will Achieve

You will play a pivotal role in guiding Pfizer through federal, state, and international regulatory requirements. Your responsibilities will include investigating and resolving compliance issues, keeping employees informed about compliance policies, and conducting audits and reviews. This role offers opportunities to enhance your skills and contribute to the success of your team by ensuring adherence to regulatory standards and fostering a collaborative environment.

Job Summary

Uphold quality and compliance standards in regulatory affairs.
Maintain Health Authority (HA) status in corporate change and dossier management systems for assigned regions or markets.
Manage daily tasks with periodic oversight from the Lead or designee.

Job Responsibilities

Ensure excellence in compliance and adherence to regulations.
Evaluate notifications assigned based on regional regulations.
Maintain HA status in corporate systems for allocated regions or markets.
Manage time effectively to meet deadlines and contribute independently.
Collaborate with Global Regulatory Affairs (GRA) colleagues to identify and escalate gaps.
Perform accurate system updates for most cases; consult with Team Lead (TL) or designee for complex issues.
Make informed decisions on straightforward cases within established guidelines.
Support updates for license withdrawals and ensure alignment with internal SOPs and policies.
Adhere to standard turnaround times and escalate potential compliance issues to management.
Assist with periodic and ad-hoc reporting and contribute to local and regional regulatory initiatives.
Support documentation of internal regulatory processes and assist with remediation activities.
Share knowledge and learning with team members.

Qualifications / Skills

Technical Skills:
- Theoretical knowledge of Regulatory Affairs/Compliance.
- Experience in Regulatory, Quality Assurance, or Production functions in the pharmaceutical or related industries.
- Strong attention to detail and diligence.
- Effective communication skills and understanding of stakeholder needs.
Standards, Processes, and Policies:
- Familiarity with Pfizer’s general standards, processes, and policies.
Behavioral Skills:
- Assertive, results-oriented, with a positive “can do” attitude and strong time management skills.
Preferred Qualifications:
- Master’s or Bachelor’s degree in Chemistry, Pharmacy, or a related life sciences field.
- 2 to 4 years of relevant experience, preferably in Regulatory, Quality, or Compliance roles.

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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Associate I – Regulatory Conformance

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