Aizant Hiring Regulatory Affairs

Aizant Regulatory Affairs Hiring Hyderabad

Aizant hiring 6–10 yrs experienced candidates in Hyderabad. MSc, BPharm, MPharm eligible for Regulatory Affairs roles.

Aizant Drug Research Solutions Pvt. Ltd. is actively hiring experienced professionals for multiple vacancies in the Regulatory Affairs department, specifically for Senior Executive and Team Lead roles at its corporate office in Dulapally, Hyderabad. This hiring drive is targeted at candidates with 6–10 years of experience in handling US and Canada regulatory submissions, making it a strong opportunity for professionals specializing in global regulatory affairs and pharmaceutical compliance.

These positions are ideal for candidates with deep expertise in CTD/eCTD submissions, regulatory strategy, and lifecycle management within regulated pharmaceutical markets. Immediate joiners are highly preferred.

Company Overview

Aizant Drug Research Solutions Pvt. Ltd. is a leading integrated pharmaceutical and clinical research organization providing end-to-end services across drug development, regulatory affairs, and clinical research. The company is known for its advanced formulation development, bioavailability studies, and regulatory support services for global pharmaceutical markets.

With strong capabilities in USFDA and international regulatory compliance, Aizant plays a critical role in supporting pharmaceutical companies in accelerating product approvals and maintaining lifecycle compliance. Its Hyderabad facility is a hub for high-quality research, regulatory documentation, and global submission management.

Job Role & Responsibilities

Senior Executive / Team Lead – Regulatory Affairs

• Define and implement regulatory strategies for US and Canada markets
• Review and supervise preparation of dossiers in CTD/eCTD formats for global submissions
• Ensure accuracy and compliance of regulatory documentation including batch records, specifications, and STP
• Handle regulatory submissions, amendments, and annual reports within timelines
• Respond to queries, deficiencies, and observations from regulatory authorities
• Manage lifecycle of regulatory submissions including variations and renewals
• Train and guide team members on updated regulatory guidelines and compliance requirements
• Coordinate with cross-functional teams including QA, production, and R&D

Eligibility / Qualifications

Candidates must have completed:

M.Sc, B.Pharm, M.Pharm, MBA

Relevant courses include: Pharmaceutical Sciences, Regulatory Affairs, Pharmaceutics, Pharmaceutical Chemistry, Clinical Research, Drug Regulatory Affairs, Quality Assurance

• Experience: 6 to 10 years in regulatory affairs for US and Canada markets
• Strong knowledge of CTD/eCTD submissions and global regulatory guidelines
• Experience in dossier review, lifecycle management, and regulatory strategy
• Leadership experience preferred for Team Lead roles
• Immediate joiners will be given preference

Location & Salary

• Job Location: Dulapally, Hyderabad
• Salary: Competitive salary based on experience and industry standards

Application Process

Interested candidates can apply by sending their updated resume to:

Email: sonyjeevitha.degala@aizant.com

Ensure your resume clearly highlights your experience in regulatory submissions, CTD/eCTD documentation, and USFDA or international market exposure to improve selection chances.

Why This Opportunity Stands Out

• Opportunity to work on US and Canada regulatory markets
• Leadership roles in regulatory affairs and submission strategy
• Exposure to global pharmaceutical compliance and lifecycle management
• Career growth in high-demand regulatory domains

FAQs

Who can apply for this role?
Candidates with M.Sc, B.Pharm, M.Pharm, or MBA and relevant experience can apply.

Is this role open for freshers?
No, this is strictly for experienced professionals with 6–10 years of experience.

What regulatory experience is required?
Hands-on experience in CTD/eCTD submissions for US and Canada markets.

Are leadership roles available?
Yes, Team Lead positions are available for experienced candidates.

How to apply?
Send your updated resume to the provided email ID.

Summary Table

Category	Details
Company	Aizant Drug Research Solutions Pvt. Ltd.
Vacancies	Senior Executive Regulatory Affairs, Team Lead Regulatory Affairs
Required Education	M.Sc, B.Pharm, M.Pharm, MBA
Experience	6 to 10 Years