Aspiro Hiring Regulatory Affairs Executive

MPharm Regulatory Affairs Executive Openings – Hyderabad

Aspiro hiring MPharm/BPharm/MSc candidates for RA Executive roles (3–5 yrs) at its injectable facility in Hyderabad.

Aspiro Pharma is recruiting experienced Regulatory Affairs professionals for its injectable manufacturing facility in Karakapatla, Hyderabad. This opportunity is ideal for candidates with strong RA expertise in CTD/eCTD submissions, ANDA filings, and global regulatory compliance specific to sterile injectable products.

Company Overview

Aspiro Pharma is a respected name in the injectable pharmaceuticals space, operating high-compliance, audit-ready manufacturing units aligned with global regulatory expectations. The organisation supports large-scale sterile operations, modern R&D infrastructure, and extensive regulatory submission pipelines for major markets including the US, EU, and ROW regions.

Job Role & Responsibilities

Senior Officer / Executive – Regulatory Affairs (Injectables)

Qualification: M.Pharm / B.Pharm / M.Sc
Experience: 3–5 years in Regulatory Affairs (Injectables)

Key Responsibilities:

• Prepare, review, and compile CTD/eCTD dossiers (Modules 1–5) for injectable products.
• Handle US ANDA submissions for USFDA and EU submissions for EMA, along with ROW regulatory filings.
• Manage post-approval changes (PAC), renewals, variations, and supplements per regulatory expectations.
• Coordinate and respond to deficiency letters, regulatory queries, and clarification requests within timelines.
• Review sterile-specific documentation: method validation reports, sterility assurance package, stability protocols, PV documents, specifications, and batch-related data.
• Collaborate with QA, QC, R&D, and Production to ensure timely availability of dossier components.
• Track submissions and regulatory commitments; maintain version control and compliance documentation.

Eligibility / Qualifications

Required Education

• M.Pharm (Pharmaceutical Regulatory Affairs, Pharmaceutics, Quality Assurance)
• B.Pharm
• M.Sc (Chemistry, Microbiology, Biotechnology)

Relevant courses: Regulatory Affairs, Pharmaceutical Quality Systems, Sterile Product Technology, Analytical Method Validation, CTD/eCTD Structure, cGMP & Data Integrity.

Experience Requirements

• 3–5 years in Regulatory Affairs for injectable products.
• Hands-on experience with CTD/eCTD, ANDA filings, PAC/variations.
• Exposure to global regulatory markets (USFDA, EMA, WHO, ROW).

Location & Salary

Work Location: Injectable Manufacturing Facility, Karakapatla, Hyderabad.
Salary: Competitive and based on RA expertise, global submission experience, and dossier handling capabilities.

Application Process

Interested and eligible candidates may send their updated resume to:
careers@aspiropharma.com
Subject Line: “Regulatory Affairs”

Candidates should ensure their profile reflects relevant RA experience, submissions handled, and market exposure.

FAQs

Is injectable experience mandatory?

Yes. Only candidates with RA experience specific to sterile injectable dossiers will be considered.

What regulatory markets should candidates be familiar with?

USFDA, EMA, and ROW submissions including ANDA and eCTD modules.

Are freshers eligible to apply?

No. Minimum 3 years of RA experience is required for this role.

Does Aspiro charge any recruitment fees?

No. Aspiro Pharma does not charge candidates at any stage of the hiring process.

Summary Table

Category	Details
Company	Aspiro Pharma, Karakapatla, Hyderabad
Vacancies	Senior Officer / Executive – Regulatory Affairs
Required Education	M.Pharm, B.Pharm, M.Sc
Experience	3–5 years in RA for injectable products