AstraZeneca Hiring Regulatory Affairs Associate

Pharma Stuff; Mumbai; Sur place; INR 900 000 - 1 500 000; Plein temps

Résumé du poste

AstraZeneca in Mumbai is seeking an Executive Regulatory Affairs to support regulatory submissions, lifecycle management, PSUR preparation, and coordination with health authorities to ensure compliance across products.

The role requires a BPharma/MPharma or Life Sciences background with hands-on experience in Indian regulatory requirements and documentation. This position is based in Mumbai and involves collaboration across cross-functional teams.

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, or related field.
• Experience in pharmaceutical regulatory affairs or quality assurance.
• Understanding of Indian regulatory requirements, GCP, and submission procedures.

Responsabilités

• Collate information and prepare responses for Health Authority queries.
• Maintain and update submission trackers with accurate regulatory documentation.
• Support development of India-specific artwork and ensure compliance.
• Prepare and submit regulatory dossiers for NDAs, additional indications, GCT applications, site registrations, and import licenses.
• Coordinate lifecycle management activities including renewals, variations, and license updates.
• Prepare and submit India-specific PSURs based on global PBRER.
• Manage submission of documents for sample testing through NIBL/CDTL.
• Support additional Regulatory Affairs projects as delegated.
• Maintain documentation records and comply with internal trackers.
• Ensure adherence to company codes of conduct, ethics, and regulatory standards.
• Assist in issue management, regulatory intelligence, and compliance activities.
• Support internal and external audits, deviations, and CAPA execution.
• Collaborate cross-functionally to ensure regulatory readiness for product launches.

Connaissances

Regulatory affairs

Quality assurance

GCP

Regulatory submissions

Formation

Bachelor’s degree in Pharmacy, Life Sciences, or related field

Description du poste

Apply for Executive Regulatory Affairs at AstraZeneca. Openings for BPharma/MPharma candidates in Mumbai.

AstraZeneca is hiring an Executive in Regulatory Affairs for its Mumbai location. This opportunity suits candidates with strong regulatory documentation skills and a solid understanding of India-specific regulatory requirements. The role supports regulatory submissions, lifecycle management, PSUR preparation, and coordination with health authorities to ensure compliance across assigned products.

Company Overview

AstraZeneca is a global, science-led biopharmaceutical leader focused on the discovery, development, and commercialization of prescription medicines. The company drives advancements in oncology, cardiovascular, renal, metabolism, respiratory, and immunology therapeutic areas. Its India operations play a key role in supporting regulatory excellence, compliance, and safe access to medicines.

Job Role & Responsibilities

• Collate information and prepare responses for Health Authority queries.
• Maintain and update submission trackers with accurate regulatory documentation.
• Support development of India-specific artwork and ensure compliance.
• Prepare and submit regulatory dossiers for NDAs, additional indications, GCT applications, site registrations, and import licenses.
• Coordinate lifecycle management activities including renewals, variations, and license updates.
• Prepare and submit India-specific PSURs based on global PBRER.
• Manage submission of documents for sample testing through NIBL/CDTL.
• Support additional Regulatory Affairs projects as delegated.
• Maintain documentation records and comply with internal trackers.
• Ensure adherence to company codes of conduct, ethics, and regulatory standards.
• Assist in issue management, regulatory intelligence, and compliance activities.
• Support internal and external audits, deviations, and CAPA execution.
• Collaborate cross-functionally to ensure regulatory readiness for product launches.

Eligibility / Qualifications

Essential:

• Bachelor’s degree in Pharmacy, Life Sciences, or related field.
• Experience in pharmaceutical regulatory affairs or quality assurance.
• Understanding of Indian regulatory requirements, GCP, and submission procedures.

Desirable:

• Post-graduate qualification.
• Experience handling PSURs, lifecycle management, and dossier preparation.

Location & Salary

Location: Mumbai, India
Salary: Not disclosed (industry-competitive as per AstraZeneca standards)

FAQs

1. Who can apply for the Executive Regulatory Affairs role at AstraZeneca?
Candidates with a BPharma, MPharma, or Life Sciences degree and experience in regulatory affairs or quality assurance.

2. Does the role require prior regulatory experience?
Yes, the position requires hands-on experience with regulatory submissions, documentation, and compliance.

3. Are freshers eligible?
No. This position requires prior relevant experience.

4. What regulatory tasks are included in this role?
Dossier preparation, PSUR submissions, lifecycle management, artwork review, and Health Authority query responses.

5. Where is the job located?
The role is based in Mumbai at AstraZeneca’s India office.