Biological E Regulatory Affairs Senior Executive/Assistant Manager Jobs – Hyderabad

Regulatory Affairs Senior Executive/Assistant Manager Jobs – Hyderabad

Apply for Regulatory Affairs Senior Executive/Assistant Manager at Biological E, Hyderabad. M. Pharma/ M. Sc/ B. Pharma eligible, 5–11 yrs experience.

Biological E, a leading vaccines and biotech company, is seeking experienced professionals for the role of Regulatory Affairs Senior Executive/Assistant Manager. This position in Genome Valley, Hyderabad, offers an exciting opportunity for professionals with expertise in Indian and global regulatory submissions to contribute to the growth of vaccines and biologics in the Indian market.

Company Overview

Biological E is a renowned biotechnology and vaccine manufacturing company in India, committed to delivering high-quality vaccines and biologics. With a strong presence in the Indian and international markets, Biological E emphasizes innovation, compliance, and scientific excellence. The organization is recognized for its contributions to public health and consistently upholds global regulatory standards, making it a trusted name in the biotech industry.

Job Role & Responsibilities

As a Regulatory Affairs Senior Executive/Assistant Manager at Biological E, your responsibilities include:

• Preparation and submission of regulatory documents to Indian Regulatory Authorities.
• Managing and expanding product portfolios across markets and territories.
• Preparation, review, and submission of applications/responses to RCGM via IBSC.
• Expertise in Indian NRA applications including CT10, CT16, CT18, CT40, Export NoC, and others.
• Proficiency with Indian NRA submission portals such as IBKP, SUGAM, NSWS, ODLS/ONDLS.
• Authoring, reviewing, and compiling regulatory packages like briefing documents, scientific packages, pre-IND packages, clinical trial documents, expedited requests, pre-qualifications, etc.
• Submission of Marketing Authorization Applications (CTD/ACTD/eCTD) for India, Emerging Markets, Regulated Markets, and WHO vaccine prequalification dossiers.
• Handling post-approval changes, variations, and comparability packages.
• Coordinating responses for India, EM, WHO, and regulated markets.
• Hands-on experience with MS Office, PDF, Track Wise, DMS, Veeva Vault, Lorenz/Pharma Ready.
• Supporting Health Agency audits for India, EM, Regulated, and WHO inspections.
• Coordinating with cross-functional teams including QA, QC, Production, Warehouse, Distribution, Marketing, and external partners.
• Reviewing artworks (labels, package inserts) and pack profiles.
• Providing additional regulatory support as required.

Eligibility / Qualifications

• Undergraduate Degree: B. Pharma in any specialization.
• Postgraduate Degree: M. Pharma or M.Sc in any relevant specialization.
• Experience: 5–11 years in Regulatory Affairs, preferably in vaccines or biologics.
• Strong knowledge of Indian regulatory submissions, NRA portals, and global regulatory frameworks.
• Excellent documentation, analytical, and communication skills.
• Ability to coordinate cross-functional teams and handle regulatory audits.

Location & Salary

Location: Genome Valley, Shameerpet, Hyderabad, India.
Salary: Not disclosed; competitive and commensurate with experience.

Application Process

Interested candidates can apply by sending their CV to HR.Intern4@biologicale.com with the subject line: Applying for “Regulatory Affairs”. Early applications are recommended due to limited openings.

FAQs

Q1: What is the required experience for this role?
A1: Candidates should have 5–11 years of experience in Regulatory Affairs within the vaccines or biologics sector.

Q2: What qualifications are required?
A2: B. Pharma or M. Pharma/ M.Sc in any relevant specialization is mandatory.

Q3: Where is the job location?
A3: Genome Valley, Shameerpet, Hyderabad, India.

Q4: Are international regulatory submissions involved?
A4: Yes, responsibilities include submissions to Emerging Markets, Regulated Markets, and WHO vaccine prequalification dossiers.

Q5: What are the primary software/tools used in this role?
A5: MS Office, PDF, Track Wise, DMS, Veeva Vault, Lorenz/Pharma Ready.

Q6: How can I apply for this position?
A6: Send your CV to HR.Intern4@biologicale.com with the subject line mentioning the role.

Q7: Is handling regulatory audits part of the job?
A7: Yes, the role involves supporting health agency audits for India, EM, Regulated, and WHO inspections.

Tagged as: Pharma Jobs in Hyderabad