AstraZeneca Hiring Regulatory Affairs Associate
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Summary Table
- FAQs
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)
Application Process
Eligible candidates can review the complete role and apply through the official career page:
Apply Here
Summary Table
| Category | Details |
|---|---|
| Company | AstraZeneca |
| Vacancies | Not specified |
| Required Education | BPharma, MPharma, Life Sciences, related fields |
| Experience | Relevant experience in Regulatory Affairs or QA |
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.
6. How can I apply?
Applications must be submitted through the AstraZeneca career portal using the link provided above.
To apply for this job please visit astrazeneca.wd3.myworkdayjobs.com.
