Website Pfizer
Job Title: Associate I – Regulatory Conformance
Location: Chennai
Industry: Pharma / Healthcare / Clinical Research
Functional Area: Regulatory
Experience: 2 to 4 years
Qualification: Master’s / Bachelor’s degree or equivalent
Application End Date: 20th August 2024
About Pfizer
Pfizer stands at the forefront of the biopharmaceutical industry, dedicated to innovating for better health. We discover, develop, manufacture, and deliver high-quality, safe, and effective prescription medicines for humans and animals. Partnering with healthcare providers, governments, and local communities worldwide, we strive to broaden access to our medicines and enhance healthcare quality and support.
Job Summary
We are looking for an Associate I in Regulatory Conformance who is dedicated to maintaining quality in compliance and conformance. This role involves managing the Health Authority (HA) status within corporate change and dossier management systems for specific regions or markets. The selected candidate will work independently with periodic supervision from the Lead or Designee.
Responsibilities
- Uphold quality and excellence in compliance and conformance.
- Evaluate assigned notifications with a sound understanding of regional regulations.
- Maintain HA status in corporate change and dossier management systems for allocated regions or markets.
- Independently manage and prioritize tasks to meet deadlines.
- Collaborate with Global Regulatory Affairs (GRA) colleagues to identify and escalate gaps promptly.
- Accurately update the system for most cases, consulting with the Team Lead or Designee for complex issues.
- Make informed decisions on straightforward cases within established guidelines and policies.
- Support system updates for license withdrawals.
- Adhere to internal Standard Operating Procedures (SOPs) and policies.
- Escalate potential compliance issues to management.
- Support periodic and ad-hoc system reports to track metrics.
- Contribute to local and regional regulatory initiatives in line with Pfizer values.
- Ensure internal regulatory processes and procedures are well documented.
- Assist in remediation activities and ADHOC tasks.
- Share knowledge and learnings with team colleagues regularly.
Technical Skills
- Theoretical knowledge of Regulatory Affairs / Compliance.
- Experience in Regulatory, Quality Assurance, Production, or related functions in the pharmaceutical or related industries.
- Attention to detail and diligence.
- Strong communication skills.
- Understanding of stakeholder needs.
Candidate Profile
- Familiarity with Pfizer’s standards, processes, and policies.
- Assertive, results-oriented, and positive attitude with strong time management skills.
- Preferred qualifications include a Master’s / Bachelor’s degree in Chemistry, Pharmacy, or related life sciences.
- 2 to 4 years of relevant experience in the pharmaceutical or related industry, particularly in Regulatory, Quality, or Compliance roles.
Apply Now
If you are committed to quality and excellence in regulatory conformance, we invite you to join our team and make a difference in the world of health. Apply by 20th August 2024 to be part of Pfizer’s journey towards better health.
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