HETERO Hiring Regulatory Affairs – Specialist

HETERO BIOPHARMA LTD; Hyderabad; Sur place; INR 900 000 - 1 500 000; Plein temps

Résumé du poste

HETERO is hiring Regulatory Affairs Specialists in Hyderabad, India. Eligible candidates hold MPharma, BPharma, or MSc degrees with 3–9 years of experience in regulatory filings and international market regulations. The role focuses on ANDA submissions, lifecycle management, and both pre- and post-approval activities.

Jeedimetla/Hyderabad location with exposure to international regulatory submissions, and opportunities to grow within a reputed pharmaceutical organization.

Qualifications

• 3–9 years of regulatory affairs experience.
• Experience with ANDA submissions and lifecycle management.
• Familiarity with CMC documentation and regulatory variations.

Responsabilités

• Preparation, review, and submission of ANDA dossiers.
• Lifecycle management of existing products and regulatory variations.
• Handling pre-approval and post-approval activities, including MAA knowledge.

Connaissances

Regulatory Affairs

ANDA submissions

Formation

MPharma

BPharma

MSc (Pharmaceutical or Life Sciences)

Description du poste

MPharma, BPharma, MSc Jobs – Regulatory Affairs Specialist Openings at HETERO (Hyderabad)

HETERO is hiring MPharma, BPharma, MSc graduates for Regulatory Affairs Specialist roles in Hyderabad. 3–9 years of experience required in ANDA, CMC, and MAA submissions

Career Opportunity at HETERO – Regulatory Affairs Specialist Roles for Experienced Pharma Professionals

HETERO, a globally recognized pharmaceutical organization, is hiring experienced professionals for the role of Regulatory Affairs Specialist in its Jeedimetla, Hyderabad unit. This is an excellent opportunity for MPharma, BPharma, or MSc graduates with experience in regulatory submissions and life cycle management to contribute to global market filings.

Role Overview: Regulatory Affairs Specialist

Department:

• Regulatory Affairs – Formulations Division (Emerging Markets & ROW)

Work Location:

• Jeedimetla, Hyderabad

Key Responsibilities

• Preparation, review, and submission of ANDA dossiers
• Lifecycle management of existing products
• Handling pre-approval and post-approval activities
• MAA (Marketing Authorization Application) knowledge
• Experience in managing CMC documentation and regulatory variations

Eligibility Criteria

Educational Qualifications:

• MPharma
• BPharma
• MSc (Pharmaceutical or Life Sciences preferred)

Experience Required:

• Minimum 3 years to 9 years in regulatory affairs, preferably in formulation filings and international market regulations

Why Join HETERO?

• Exposure to international regulatory submissions
• Strong focus on formulation and product life cycle support
• Career growth in a reputed pharmaceutical organization

Summary Table

• Company Name: HETERO
• Current Vacancies: Regulatory Affairs – Specialist
• Required Education: MPharma, BPharma, MSc
• Experience Required: 3–9 years in Regulatory Affairs (Formulations)