Aizant Hiring Regulatory Affairs Specialist

Regulatory Affairs Specialist 6–8 Yrs – Aizant Hyderabad

Aizant hiring experienced Regulatory Affairs professional for EU/UK markets in Hyderabad. 6–8 years RA experience required.

Aizant Drug Research Solutions is looking for an experienced Regulatory Affairs professional with strong exposure to the EU and UK markets. The role calls for someone who can independently prepare, review and manage regulatory submissions for oral solid dosage (OSD) and formulation projects. Candidates with 6–8 years of hands-on RA experience and immediate joining availability will be preferred.

Company Overview

Aizant Drug Research Solutions is a well-recognised CRO and pharmaceutical services organisation offering end-to-end solutions across formulation development, analytical research, bioequivalence studies and regulatory support. With a strong presence in regulated markets and a proven track record in dossier development, Aizant delivers high-quality, compliant documentation for global submissions. The company emphasises scientific accuracy, regulatory intelligence and on-time execution.

Job Role & Responsibilities

Regulatory Affairs Specialist – EU/UK Markets (6–8 Years)

• Prepare, compile and submit high-quality regulatory dossiers as per EU and UK regulatory frameworks.
• Coordinate with cross-functional teams (CFTs) including QA, QC, ADL, F&D and packaging to gather required technical inputs.
• Maintain and update regulatory documentation, databases and submission trackers.
• Engage effectively with internal stakeholders and external regulatory authorities.
• Apply strong knowledge of EU guidelines, submission pathways and regulatory procedures.
• Review quality documents for accuracy, GMP alignment and dossier readiness.
• Manage post-approval variations specific to EU and UK markets.
• Respond to regulatory queries with clear, timely and well-supported justifications.
• Track evolving regulatory expectations and keep relevant departments informed.

This role demands strong attention to detail, regulatory interpretation skills and the ability to manage complex submission timelines.

Eligibility / Qualifications

• Experience: 6–8 years of Regulatory Affairs experience; EU market knowledge mandatory.
• Qualification: B.Pharm, M.Pharm or relevant life-science degree.
• Strong understanding of CTD/eCTD formats, Module 1–5 structures and lifecycle management.
• Familiarity with OSD, formulations, pharmaceutical development and quality systems.

Relevant courses (comma-separated): B.Pharm, M.Pharm (Regulatory Affairs), M.Pharm Pharmaceutics, Diploma in Regulatory Affairs, CTD/eCTD certification, ICH guidelines training, QA/CMC documentation courses.

Location & Salary

• Location: Hyderabad (Kompally).
• Work Mode: On-site.
• Salary: Not disclosed; based on experience.

Application Process

Interested candidates can send their resume to:
raghuveera.vutla@aizant.com

Immediate joiners will be given preference.

FAQs

What experience is required?

6–8 years in Regulatory Affairs with strong exposure to EU and UK submissions.

Is EU market experience mandatory?

Yes. EU/UK regulatory knowledge is essential for this role.

What dosage forms are preferred?

OSD and formulations experience adds strong value.

Is this a remote role?

No. The role is based on-site at Hyderabad (Kompally).

Who should apply?

Experienced RA professionals comfortable with dossier compilation, variations, CMC review and regulatory communication.

---

Summary Table

Category	Details
Company	Aizant Drug Research Solutions
Vacancies	Regulatory Affairs Specialist – EU/UK Markets
Required Education	B.Pharm, M.Pharm, RA Certifications, CTD/eCTD Training
Experience	6–8 years in Regulatory Affairs (EU/UK preferred)