Noronic Pharma Hiring Sr. Officer – Regulatory Affairs

Sr. Officer – Regulatory Affairs | B.Pharm / M.Pharm | Noronic Pharma Ahmedabad

Apply for Senior Officer – Regulatory Affairs at Noronic Pharma, Ahmedabad. 3–7 yrs exp. CTD/ACTD, PV, Stability, BMR/BPR, Artwork & BE Study.

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Noronic Pharmaceutical Pvt. Ltd., a fast-growing pharmaceutical organization based in Ahmedabad, is inviting applications for the position of Senior Officer – Regulatory Affairs. This role is designed for experienced regulatory professionals who have hands-on expertise in CTD/ACTD submissions, process validation, stability documentation, BMR/BPR preparation, and regulatory artwork review. If you’re a pharma professional passionate about compliance, documentation, and international dossier management, Noronic offers a great platform for career advancement.

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Company Overview

Noronic Pharmaceutical Pvt. Ltd., headquartered in Gota, Ahmedabad, is a dynamic and quality-driven pharmaceutical manufacturing company committed to providing high-quality, affordable medicines. With its focus on Regulatory Affairs, Formulation Development, and Quality Systems, Noronic ensures compliance with WHO-GMP, cGMP, and international regulatory standards.

The company specializes in formulating and exporting finished pharmaceutical products across multiple therapeutic areas, catering to both domestic and global markets. By integrating science, innovation, and stringent quality processes, Noronic maintains its position as a trusted partner in global healthcare.

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Job Role & Responsibilities

Designation: Senior Officer – Regulatory Affairs

Department: Regulatory Affairs
Location: Gota, Ahmedabad
Experience: 3–7 Years (Preferred range)

As a Senior Officer – Regulatory Affairs, you will be responsible for end-to-end regulatory documentation, dossier preparation, submission, and compliance management to support product registration and market authorization in regulated and semi-regulated markets.

Key Responsibilities:

• Preparation, review, and compilation of CTD / ACTD Modules (1 to 5) for global submissions.
• Manage Process Validation (PV) documentation and ensure alignment with regulatory guidelines.
• Handle Stability Protocols, Stability Study Reports, and ensure regulatory compliance for product lifecycle documentation.
• Prepare Product Dossiers, PDRs, and related regulatory documents for domestic and international markets.
• Review artwork, carton designs, shade cards, and printed proofs in line with approved specifications and branding.
• Prepare and maintain BMR/BPR (Batch Manufacturing & Packaging Records) as per cGMP standards.
• Develop and review SmPC / Leaflet / Insert (PIL) documents and ensure they align with product specifications and regulatory requirements.
• Execute Analytical Method Validation (AMV) and ensure consistency with approved test procedures.
• Handle Certificate of Analysis (CoA) and Method of Analysis (MoA) documentation for finished products.
• Manage BE (Bioequivalence) study documentation, CDP (Control Data Point) matching, and coordinate with CROs as required.
• Review and update finished product specifications in alignment with regulatory expectations.
• Provide regulatory support to QA, QC, and Production during audits, inspections, and technical queries.

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Eligibility / Qualifications

Educational Background:

• B.Pharm / M.Pharm / M.Sc (Pharmaceutical Sciences, Quality Assurance, Regulatory Affairs, Industrial Pharmacy, or Analytical Chemistry)

Relevant Courses:
Pharmaceutical Regulatory Affairs, CTD/ACTD Dossier Preparation, Analytical Validation, Quality Management, International Drug Regulations, GMP Documentation, Product Lifecycle Management.

Experience:

• 3–7 years of experience in Regulatory Affairs, preferably in pharma formulation or export documentation.

Technical Skills Required:

• Strong knowledge of CTD/ACTD module preparation and dossier compilation.
• Experience in AMV, PV, Stability, and BE study documentation.
• Familiar with artwork checks, packaging leaflets, BMR/BPR, and specifications review.
• Sound understanding of regulatory guidelines (ICH, WHO, USFDA, EMA, and ASEAN).
• Ability to prepare and review CoA, MoA, and Specification documents.

Soft Skills:

• Meticulous attention to detail with excellent documentation accuracy.
• Strong communication and presentation skills.
• Team player capable of cross-functional coordination.

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Location & Salary

Location: Gota, Ahmedabad, Gujarat
Company: Noronic Pharmaceutical Pvt. Ltd.
Salary: Competitive, based on experience and industry standards.
Employment Type: Full-Time, Permanent

Noronic offers performance-based incentives, professional growth programs, and opportunities to work on international submissions for regulated markets.

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Application Process

Interested and eligible candidates can share their updated resumes directly with the HR team. Please mention “Application – Senior Officer Regulatory Affairs” in the subject line for quick processing.

Email: hr@noronicpharma.com

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Why Join Noronic Pharmaceutical Pvt. Ltd.?

• Work in a fast-growing, WHO-GMP certified pharma organization with a focus on regulatory excellence.
• Opportunity to handle global dossier submissions and CTD/ACTD documentation.
• Collaborative and learning-focused environment with career advancement opportunities.
• Exposure to multi-market regulatory frameworks and quality compliance processes.
• Participate in international regulatory operations and BE study support functions.

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FAQs

1. What qualifications are required for this role?
Candidates must hold a B.Pharm, M.Pharm, or M.Sc degree with 3–7 years of experience in Regulatory Affairs.

2. Is experience with CTD/ACTD dossiers mandatory?
Yes, hands-on experience in preparing and reviewing CTD/ACTD (Modules 1–5) is essential.

3. What skills are preferred for this position?
Proficiency in AMV, PV, BMR/BPR, artwork review, and BE study documentation is required.

4. Is this a full-time role?
Yes, this is a full-time, permanent position at Noronic Pharma, Ahmedabad.

5. How can I apply?
Send your CV to hr@noronicpharma.com with the subject line “Senior Officer – Regulatory Affairs.”

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Job Summary Table

Category	Details
Company	Noronic Pharmaceutical Pvt. Ltd.
Vacancies	Senior Officer – Regulatory Affairs
Required Education	B.Pharm / M.Pharm / M.Sc
Experience	3–7 Years
Location	Gota, Ahmedabad, Gujarat
Email	hr@noronicpharma.com
Salary	Competitive, based on experience