Graviti Hiring Regulatory Affairs Executive/Sr Executive

M.Pharm Regulatory Affairs Vacancies – Hyderabad

Regulatory Affairs Executive/Sr Executive roles for M.Pharm, B.Pharm candidates with 2–5 years US ANDA experience in Hyderabad.

Graviti Pharma Pvt. Ltd. is strengthening its Regulatory Affairs team to support an expanding US generics portfolio. This opportunity is designed for professionals with hands-on US FDA ANDA exposure who want to work across the complete lifecycle of generic drug submissions. The role offers meaningful responsibility, regulatory depth, and long-term career growth within a quality-focused pharmaceutical organization.

Company Overview

Graviti Pharma Pvt. Ltd. is a growing pharmaceutical company focused on the development and regulatory approval of high-quality generic formulations for regulated markets. With a strong emphasis on compliance, data integrity, and regulatory excellence, Graviti Pharma supports multiple US FDA filings and works closely with cross-functional teams spanning formulation development, analytical sciences, quality assurance, manufacturing, and bioequivalence.

The organization is steadily building its presence in the US generics space by delivering robust ANDA submissions that meet stringent FDA expectations. Professionals joining Graviti Pharma gain exposure to real-world regulatory challenges and global filing strategies.

Job Role & Responsibilities

Regulatory Affairs – US Generics (Formulations)

The selected candidate will be responsible for end-to-end regulatory activities related to US ANDA submissions for finished dosage forms, with a strong focus on CMC documentation and FDA correspondence.

Key responsibilities include:

• Preparation, compilation, and submission of US ANDA dossiers in eCTD format
• Authoring, reviewing, and updating Module 3 (CMC) sections for oral solid dosage formulations
• Handling US FDA deficiency letters including DRLs, IRs, and CRLs
• Preparation of responses to FDA queries within defined timelines
• Coordination with Formulation R&D, Analytical Development, QA, Manufacturing, and BE teams
• Supporting post-approval changes, amendments, supplements, and annual reports
• Ensuring compliance with US FDA regulations, guidance documents, and ICH requirements
• Maintaining accurate regulatory tracking, documentation, and submission archives

This role plays a critical part in ensuring timely approvals and sustained compliance in the highly competitive US generics market.

Eligibility / Qualifications

Educational Background

Candidates must hold one of the following qualifications:

M.Pharm, B.Pharm, M.Sc (Pharmaceutical Sciences or Chemistry)

Experience Requirements

• 2 to 5 years of relevant experience in US FDA Regulatory Affairs
• Hands-on experience with US ANDA submissions for generic formulations
• Exposure to eCTD publishing and lifecycle management
• Experience in handling FDA correspondence and deficiency responses

Technical & Regulatory Skills

• Strong understanding of ANDA regulations, CMC documentation, and FDA guidance
• Working knowledge of ICH guidelines and US FDA submission requirements
• Experience with oral solid dosage forms is preferred
• Strong coordination, documentation, and regulatory writing skills

Location & Career Growth

Job Location: Hyderabad, Telangana

Hyderabad is one of India’s largest pharmaceutical regulatory hubs, offering long-term growth opportunities in US regulatory affairs, global submissions, and leadership roles. Graviti Pharma provides direct exposure to multiple US filings, making this role valuable for professionals aiming to advance in high-CPC regulatory affairs careers.

Salary will be competitive and commensurate with experience and expertise.

Application Process

Interested candidates can apply through any of the following options:

• Email your updated resume to: Rajesh.a@gravitipharma.com
• Contact: 7075201677 (WhatsApp or calls during office hours)
• LinkedIn outreach for initial discussion

Candidates are advised to mention their total experience, US ANDA exposure, and notice period while applying.

Why Choose a Career in US Regulatory Affairs?

Regulatory Affairs professionals working on US ANDA submissions are among the most in-demand roles in the pharmaceutical industry. Expertise in CMC documentation, FDA correspondence, and eCTD submissions directly impacts product approvals, market access, and revenue generation. This makes US regulatory roles highly stable, high-paying, and globally transferable.

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Frequently Asked Questions (FAQs)

Is US ANDA experience mandatory for this role?

Yes. Candidates must have hands-on experience in US FDA ANDA submissions and CMC documentation.

Are freshers eligible to apply?

No. This role requires a minimum of 2 years of relevant US regulatory affairs experience.

What dosage forms are handled in this role?

The primary focus is on finished dosage forms, with preference for oral solid dosage formulations.

Does this role involve post-approval work?

Yes. The position includes handling amendments, supplements, annual reports, and lifecycle management activities.

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Company	Graviti Pharma Pvt. Ltd.
Vacancies	Regulatory Affairs Executive, Regulatory Affairs Senior Executive
Required Education	M.Pharm, B.Pharm, M.Sc (Pharma/Chemistry)
Experience	2–5 Years