Provis Hiring Regulatory Affairs

Provis Biolabs Private Limited; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Provis Biolabs in Hyderabad, Telangana, is hiring Regulatory Affairs Biologics professionals with 3–5 years of hands-on regulatory experience in biologics. The role focuses on end-to-end regulatory documentation, global submissions, and cross-functional coordination within a pharma/biotech setting.

The candidate will manage DMFs, CTD/ACTD/eCTD/NeeS submissions for US, EU, and ROW, and collaborate with QA, analytical development, and R&D to ensure compliant data and timely submissions across

Qualifications

• 3 to 5 years of hands-on experience in regulatory affairs with a focus on biologics.
• Experience in DMF preparation and global regulatory submissions.
• Knowledge of CTD, ACTD, eCTD, and NeeS submission formats.
• Experience working with US, EU, and ROW markets.

Responsibilities

• Prepare, compile, and submit DMFs for regulated markets.
• Author and review CTD and ACTD dossiers.
• Prepare Quality Overall Summary (QOS) documents for biologics.
• Coordinate with QA, Analytical Development, and R&D to collect data.
• Submit dossiers in eCTD and NeeS formats for US, EU, ROW.
• Support audits, inspections, and internal regulatory reviews.

Skills

Regulatory documentation

Coordination abilities

Independent work

Attention to regulatory compliance

Biologics regulatory guidelines

Self-driven mindset

Education

M.Sc., Ph.D., B.Pharm, M.Pharm

Job description

Regulatory Affairs Biologics Jobs for M.Pharm, MSc in Hyderabad

Provis Biolabs hiring Regulatory Affairs Biologics professionals in Hyderabad. MSc, M.Pharm eligible. 3–5 years experience required.

Provis Biolabs is expanding its regulatory affairs team and inviting experienced professionals with strong exposure to biologics and regulated markets. This opportunity is ideal for candidates who have hands‑on experience in regulatory dossier preparation, global submissions, and cross‑functional coordination within a pharmaceutical or biotechnology environment. Based in Hyderabad, this role offers a stable career path in one of the most critical functions of the biopharmaceutical industry, directly supporting compliance, product approvals, and global market access.

Company Overview

Provis Biolabs is a growing pharmaceutical and biotechnology‑focused organization with a strong emphasis on quality, compliance, and innovation. The company operates in regulated markets and supports the development and commercialization of complex products, including biologics. With a compliance‑driven culture and experienced leadership, Provis Biolabs has established itself as a reliable partner in the global healthcare and life sciences ecosystem.

The organization follows stringent regulatory standards aligned with US FDA, EMA, and other international health authorities. Its teams work closely across quality assurance, analytical development, research and development, and regulatory affairs to ensure products meet global regulatory expectations. Provis Biolabs continues to invest in skilled professionals who understand the evolving regulatory landscape and can contribute to long‑term growth and patient safety.

Job Role & Responsibilities

The Regulatory Affairs – Biologics professional will be responsible for end‑to‑end regulatory documentation and submission activities for regulated markets. This role requires a strong understanding of biologics regulations, technical documentation, and global submission formats.

Key Responsibilities

• Preparation, compilation, and submission of Drug Master Files (DMFs) for regulated markets
• Authoring and reviewing CTD and ACTD dossiers in compliance with current regulatory guidelines
• Preparation of Quality Overall Summary (QOS) documents for biologics products
• Handling regulatory documentation‑related customer queries and deficiency responses
• Submission of dossiers in eCTD and NeeS formats for US, EU, and Rest of World (ROW) markets
• Coordination with Quality Assurance, Analytical Development, and R&D teams to collect, verify, and align data
• Ensuring compliance with US FDA, EMA, and other global regulatory authority requirements
• Tracking regulatory changes and implementing updates in documentation practices
• Maintaining accurate regulatory records and version control of submission documents
• Supporting audits, inspections, and internal regulatory reviews when required

This role plays a direct part in ensuring timely approvals, regulatory compliance, and uninterrupted supply of biologics to global markets. Strong attention to detail and regulatory knowledge are essential.

Eligibility / Qualifications

Candidates applying for this Regulatory Affairs Biologics position must meet the following educational and professional criteria.

Required Education

M.Sc., Ph.D., B.Pharm, M.Pharm in relevant disciplines such as Pharmaceutical Sciences, Biotechnology, Biochemistry, Microbiology, Life Sciences

Experience Requirements

• 3 to 5 years of hands‑on experience in Regulatory Affairs with a focus on biologics
• Proven experience in DMF preparation and global regulatory submissions
• Practical knowledge of CTD, ACTD, eCTD, and NeeS submission formats
• Experience working with regulated markets including US, EU, and ROW

Desired Skills

• Strong regulatory documentation and technical writing skills
• Excellent communication and coordination abilities
• Ability to work independently with minimal supervision
• High level of accuracy and attention to regulatory compliance
• Familiarity with current regulatory guidelines for biologics
• Self‑driven mindset with the ability to manage multiple regulatory timelines

Location & Salary

Working Location: Hyderabad, Telangana

Hyderabad remains one of India’s leading pharmaceutical and biotechnology hubs, offering excellent career growth, industry exposure, and access to global regulatory projects.

Salary: Competitive and commensurate with experience. Compensation will align with industry standards for regulatory affairs biologics roles and will be discussed during the interview process.

Why Choose a Career in Regulatory Affairs – Biologics

Regulatory affairs is a high‑value function within the pharmaceutical and biotechnology industry. Professionals in biologics regulatory affairs play a critical role in ensuring patient safety, regulatory compliance, and timely market access for complex biological products.

This role offers exposure to high CPC career paths such as regulatory affairs specialist, regulatory affairs manager, biologics compliance expert, and global regulatory submissions professional. These roles are among the most searched and highest‑paying positions in the pharma and biotech job market.

Working at Provis Biolabs provides the opportunity to contribute to healthcare advancement while building expertise in global regulatory frameworks.

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Frequently Asked Questions (FAQs)

What qualifications are required for this Regulatory Affairs Biologics role?

Candidates with M.Sc., Ph.D., B.Pharm, or M.Pharm qualifications in pharmaceutical or life sciences disciplines are eligible.

Is experience mandatory for this position?

Yes. A minimum of 3 to 5 years of experience in biologics regulatory affairs is required.

Which markets will I work on?

The role involves submissions and regulatory activities for US, EU, and Rest of World markets.

Is this role suitable for freshers?

No. This position is designed for experienced regulatory affairs professionals with prior biologics exposure.

Where is the job located?

The working location is Hyderabad, Telangana.

How can I apply?

You can apply by emailing your CV to [e-mail] or contacting via WhatsApp at 7353245 00.

Regulatory Affairs Career Growth

Regulatory affairs professionals with biologics experience are in high demand due to the complexity of biological products and evolving global regulations. This role can lead to senior regulatory affairs positions, regulatory strategy roles, and leadership opportunities in multinational pharmaceutical and biotechnology companies.

By joining Provis Biolabs, candidates gain exposure to regulated markets, high‑value compliance projects, and long‑term career stability in the healthcare sector.

Summary Table

Company: Provis Biolabs

Vacancies: Regulatory Affairs Executive – Biologics

Required Education: M.Sc., Ph.D., B.Pharm, M.Pharm

Experience: 3–5 Years

Tagged as: Analytical Development, Analytical Research and Development, Biologics, Documentation, eCTD, GMP, Regulatory Compliance, Regulatory Submissions