Regulatory Affairs Jobs at Provis Biolabs
Provis Biolabs Private Limited is expanding its Regulatory Affairs – Biologics team and inviting experienced regulatory professionals to join its Hyderabad operations. This opportunity is designed for candidates with hands-on experience in biologics regulatory documentation, global submissions, and compliance activities across regulated markets. Regulatory Affairs Jobs at Provis Biolabs
The role offers exposure to US FDA, EMA, and other international regulatory authorities, making it an excellent career opportunity for professionals seeking long-term growth in regulatory affairs within the pharmaceutical and biotechnology industry.
Company Overview
Provis Biolabs Private Limited is a growing pharmaceutical and biotechnology-focused organization with a strong commitment to quality, compliance, and regulatory excellence. The company supports the development, registration, and commercialization of complex pharmaceutical and biologics products for regulated global markets. Regulatory Affairs Jobs at Provis Biolabs
With operations aligned to international regulatory standards such as US FDA, EMA, and other global health authorities, Provis Biolabs maintains a compliance-driven culture supported by experienced leadership and skilled professionals. The organization works closely across regulatory affairs, quality assurance, analytical development, and research teams to ensure timely approvals and consistent regulatory compliance.
Provis Biolabs continues to invest in regulatory talent capable of navigating evolving global regulations, supporting biologics product approvals, and ensuring uninterrupted market access. Regulatory Affairs Jobs at Provis Biolabs
Job Details
- Company Name: Provis Biolabs Private Limited
- Job Title: Regulatory Affairs Executive – Biologics
- Employment Type: Full Time
- Job Location: Hyderabad, Telangana
- Industry: Pharmaceutical / Biotechnology
- Job Category: Regulatory Affairs – Biologics
Job Role & Responsibilities
The Regulatory Affairs – Biologics professional will be responsible for managing end-to-end regulatory documentation and submission activities for biologics products intended for regulated markets. This role requires strong technical knowledge of biologics regulations, submission formats, and cross-functional coordination. Regulatory Affairs Jobs at Provis Biolabs
Key Responsibilities
- Preparation, compilation, and submission of Drug Master Files (DMFs) for regulated markets
- Authoring, reviewing, and maintaining CTD and ACTD dossiers in line with current regulatory guidelines
- Preparation of Quality Overall Summary (QOS) documents for biologics products
- Handling regulatory queries, deficiency responses, and customer documentation requests
- Submitting dossiers in eCTD and NeeS formats for US, EU, and Rest of World (ROW) markets
- Coordinating with Quality Assurance, Analytical Development, and R&D teams to collect and verify regulatory data
- Ensuring compliance with US FDA, EMA, and other global regulatory authority requirements
- Monitoring regulatory guideline updates and implementing changes in documentation practices
- Maintaining accurate regulatory records, submission trackers, and version control
- Supporting internal audits, inspections, and regulatory reviews as required
This role plays a critical part in ensuring regulatory compliance, timely approvals, and continuous supply of biologics products to global markets.
Eligibility / Qualifications
Required Education
Candidates must possess one of the following qualifications in relevant disciplines:
- M.Sc
- Ph.D
- B.Pharm
- M.Pharm
Relevant fields include Pharmaceutical Sciences, Biotechnology, Biochemistry, Microbiology, and Life Sciences. Regulatory Affairs Jobs at Provis Biolabs
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
- Working knowledge of CTD, ACTD, eCTD, and NeeS submission formats
- Experience handling submissions for US, EU, and ROW markets
Regulatory Affairs Jobs at Provis Biolabs
Desired Skills
- Strong regulatory documentation and technical writing capabilities
- Excellent communication and cross-functional coordination skills
- Ability to work independently and manage multiple regulatory timelines
- High attention to detail and strong compliance mindset
- Sound understanding of current regulatory guidelines for biologics
- Self-driven and organized approach to regulatory project management
Regulatory Affairs Jobs at Provis Biolabs
Location & Salary
Job Location
Hyderabad, Telangana
Hyderabad is one of India’s leading pharmaceutical and biotechnology hubs, offering strong industry exposure, global regulatory projects, and long-term career opportunities. Regulatory Affairs Jobs at Provis Biolabs
Salary
Compensation will be competitive and commensurate with experience. Salary will align with industry standards for regulatory affairs biologics roles and will be discussed during the interview process. Regulatory Affairs Jobs at Provis Biolabs
Why Choose a Career in Regulatory Affairs – Biologics
Regulatory Affairs is a critical and high-impact function in the pharmaceutical and biotechnology industry. Professionals working in biologics regulatory affairs directly support patient safety, regulatory compliance, and global market access for complex biological products. Regulatory Affairs Jobs at Provis Biolabs
This role offers exposure to high-value career paths such as:
- Regulatory Affairs Specialist – Biologics
- Global Regulatory Submissions Expert
- Regulatory Affairs Manager
- Biologics Compliance and Strategy Roles
These positions consistently rank among the highest-demand and highest-paying roles in the pharma and biotech job market.
At Provis Biolabs, professionals gain hands-on experience with regulated markets, evolving biologics regulations, and global submission strategies, building a strong foundation for long-term career growth. Regulatory Affairs Jobs at Provis Biolabs
Application Process
Interested and eligible candidates can apply using the following details:
Email: careers@provisbiolabs.com
WhatsApp: 7353245003
Candidates should send an updated resume highlighting experience in regulatory affairs, biologics documentation, and global submissions.
Important Notice:
Provis Biolabs does not charge any registration fees, security deposits, or application fees at any stage of the recruitment process. Candidates are advised to remain cautious of fraudulent job offers or payment requests.
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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 regulatory activities for US, EU, and Rest of World markets.
Is this role suitable for freshers?
No. This position is intended for experienced regulatory affairs professionals.
Where is the job located?
The job location is Hyderabad, Telangana.
How can I apply?
You can apply by emailing your resume to careers@provisbiolabs.com or contacting via WhatsApp at 7353245003.
Regulatory Affairs Career Growth
Regulatory affairs professionals with biologics experience are in strong demand due to the complexity of biological products and evolving global regulatory frameworks. This role can lead to senior regulatory positions, regulatory strategy roles, and leadership opportunities in multinational pharmaceutical and biotechnology organizations. Regulatory Affairs Jobs at Provis Biolabs
Joining Provis Biolabs provides exposure to regulated markets, compliance-driven projects, and long-term career stability in the healthcare sector.
Summary Table
| Category | Details |
|---|---|
| Company | Provis Biolabs Private Limited |
| Job Role | Regulatory Affairs Executive – Biologics |
| Education | M.Sc, Ph.D, B.Pharm, M.Pharm |
| Experience | 3–5 Years |
| Job Type | Full Time |
| Location | Hyderabad, Telangana |
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