Pulse Pharma Hiring Regulatory Executive

M.Pharm Regulatory Executive Jobs in Hyderabad | Pulse Pharma

Pulse Pharma hiring Regulatory Executive (3–5 yrs). M.Pharm/MSc candidates for biologics & biosimilars roles in Hyderabad.

Pulse Pharma is expanding its regulatory affairs team and is inviting experienced professionals to be part of its fast-growing biologics and biosimilars portfolio. Based in Hyderabad’s thriving biotech ecosystem, this opportunity is ideal for regulatory professionals who want to work on high-impact pharmaceutical products that reach global markets. The role offers hands-on exposure to complex regulatory submissions, cross-functional collaboration, and long-term career growth within a research-driven pharmaceutical organization.

Company Overview

Pulse Pharma is a research-focused pharmaceutical company headquartered in Hyderabad, with over two decades of progressive growth in the life sciences sector. The organization specializes in the development, manufacturing, and global supply of high-quality biologics and biosimilars. Known for its strong scientific foundation and regulatory compliance culture, Pulse Pharma operates with a clear mission to improve global healthcare access through innovation, quality, and ethical practices.

The company’s biologics pipeline addresses critical therapeutic areas and follows stringent international regulatory standards. Pulse Pharma provides professionals with an environment that encourages learning, accountability, and contribution to meaningful healthcare advancements.

Job Role & Responsibilities – Regulatory Executive (Biologics & Biosimilars)

As a Regulatory Executive, you will play a key role in managing regulatory submissions and lifecycle activities for biologics and biosimilar products. This position demands strong technical knowledge, regulatory intelligence, and the ability to coordinate with multiple internal teams.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for biologics and biosimilars to global regulatory authorities.
• Handle submissions to CDSCO, USFDA, EMA, and other international agencies as applicable.
• Manage regulatory activities related to new product filings, amendments, variations, renewals, and post-approval changes.
• Respond to regulatory queries, deficiency letters, and agency communications within defined timelines.
• Review regulatory guidelines and stay updated on changes related to biologics and biosimilars.
• Support review and approval of product labeling, change controls, and regulatory documentation.
• Collaborate with R&D, Quality Assurance, Manufacturing, and Clinical teams to ensure end-to-end compliance.
• Maintain regulatory databases, submission trackers, and document archives.

Eligibility / Qualifications

Educational Qualifications

M.Pharm, M.Sc. Biotechnology, M.Sc. Life Sciences, Pharmaceutical Biotechnology, Regulatory Affairs, Industrial Pharmacy, Biopharmaceutical Sciences

Experience Requirements

• 3 to 5 years of hands-on experience in regulatory affairs.
• Mandatory experience in biologics and/or biosimilars regulatory submissions.
• Strong exposure to regulatory dossier preparation (Module 2 and Module 3 preferred).
• Working knowledge of IND, NDA, BLA, ANDA pathways.
• Familiarity with ICH, WHO, CDSCO, USFDA, and EMA guidelines.

Key Skills

• Regulatory dossier writing and submission management
• CMC documentation for biologics
• Post-approval regulatory maintenance
• Regulatory intelligence and compliance tracking
• Strong documentation and communication skills
• Ability to work in a deadline-driven pharmaceutical environment

Location & Salary

• Job Location: Hyderabad, Telangana
• Industry: Pharmaceuticals – Biologics & Biosimilars
• Employment Type: Full-Time
• Salary: Competitive and aligned with industry standards (based on experience and expertise)

Application Process

Interested candidates should email their updated resume along with a brief cover letter highlighting their biologics regulatory experience.

Email: talenthunt@pulsepharma.net
Subject Line: Application for Regulatory Executive – Biologics

Early applications are encouraged. Only candidates with relevant regulatory affairs experience in biologics or biosimilars will be shortlisted.

Frequently Asked Questions (FAQs)

Is experience in biologics mandatory for this role?
Yes. Candidates must have hands-on experience in biologics and/or biosimilars regulatory affairs.

Can candidates with small molecule regulatory experience apply?
This role is specifically focused on biologics and biosimilars. Candidates without relevant exposure may not be considered.

Is this role suitable for M.Pharm freshers?
No. A minimum of 3 years of regulatory affairs experience is required.

Does Pulse Pharma handle global regulatory submissions?
Yes. The role involves exposure to Indian and international regulatory agencies including CDSCO, USFDA, and EMA.

What growth opportunities are available?
Pulse Pharma offers long-term career progression, exposure to global regulatory projects, and opportunities to work on innovative biologic therapies.

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Company                           Pulse Pharma
Vacancies                           Not Disclosed
Required Education           M.Pharm, M.Sc Biotechnology, M.Sc Life Sciences
Experience                         3–5 Years