Royal Hiring Regulatory Affairs Executive

Royal Pharma Regulatory Affairs Executive | MPharm

Royal Pharmaceuticals hiring Regulatory Affairs Executive (API) in Boisar. B.Pharm, M.Pharm, M.Sc Chemistry candidates with 3-5 years experience can apply.

Pharmaceutical professionals looking for Regulatory Affairs jobs in the API sector have an excellent opportunity to join Royal Pharmaceuticals Industries Pvt. Ltd. The company is currently hiring experienced candidates for the position of Regulatory Affairs Executive (API) at its Boisar, Maharashtra facility.

This recruitment opportunity is ideal for candidates with expertise in regulatory documentation, DMF preparation, CTD/eCTD submissions, compliance management, and API regulatory affairs. Professionals with B.Pharm, M.Pharm, or M.Sc Chemistry qualifications and experience in the Active Pharmaceutical Ingredients industry can apply for this role.

As regulatory requirements continue to evolve across global pharmaceutical markets, experienced Regulatory Affairs professionals play a crucial role in ensuring product compliance, timely approvals, and successful market access. Candidates searching for pharmaceutical regulatory affairs jobs, API regulatory compliance careers, drug master file specialist jobs, GMP compliance positions, and pharmaceutical documentation roles will find this opening particularly relevant.

Company Overview

Royal Pharmaceuticals Industries Pvt. Ltd. is a pharmaceutical organization engaged in the manufacturing and development of Active Pharmaceutical Ingredients (APIs). The company focuses on maintaining global quality standards, regulatory compliance, and operational excellence across its manufacturing and regulatory functions.

The pharmaceutical industry increasingly relies on strong regulatory systems to support product registrations and international market expansion. Royal Pharmaceuticals continues to strengthen its Regulatory Affairs team by recruiting professionals capable of handling complex documentation requirements and supporting global regulatory submissions.

Working with Royal Pharmaceuticals offers exposure to API regulatory projects, compliance activities, dossier preparation, and collaboration with cross-functional pharmaceutical teams.

Primary Keyword: Regulatory Affairs Executive API Jobs

Job Role & Responsibilities

Regulatory Affairs Executive (API)

The selected candidate will be responsible for supporting regulatory activities related to Active Pharmaceutical Ingredients, ensuring compliance with global regulatory requirements, and coordinating documentation submissions.

Key Responsibilities

• Preparation, review, and compilation of regulatory dossiers.
• Preparation and maintenance of Drug Master Files (DMFs).
• Handling regulatory submissions, renewals, amendments, and variations.
• Review technical documents, specifications, analytical reports, and supporting regulatory data.
• Coordinate with Quality Assurance, Quality Control, Production, and Research & Development teams.
• Track regulatory commitments and ensure timely closure of regulatory actions.
• Support customer audits, regulatory inspections, and compliance reviews.
• Maintain regulatory databases and document management systems.
• Ensure adherence to current Good Manufacturing Practices (cGMP) and global regulatory guidelines.
• Assist in responding to regulatory authority queries and customer information requests.

Key Regulatory Areas

The position requires practical knowledge of:

• DMF (Drug Master File)
• CEP Documentation
• CTD Documentation
• eCTD Submissions
• Regulatory Compliance Management
• GMP Documentation
• Technical Data Compilation
• Regulatory Lifecycle Management

Professionals with experience in international regulatory filing processes and API registrations will have an advantage during the selection process.

Eligibility / Qualifications

Candidates must possess one of the following qualifications:

• B.Pharm
• M.Pharm
• M.Sc Chemistry

Relevant Educational Courses

Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), Pharmaceutical Regulatory Affairs, Pharmaceutical Quality Assurance, Pharmaceutical Analysis, Industrial Pharmacy, Pharmaceutical Chemistry, M.Sc Organic Chemistry, M.Sc Analytical Chemistry, M.Sc Chemistry, Drug Regulatory Affairs, API Regulatory Compliance.

Experience Requirements

Required Experience

Experience: 3 to 5 Years

Industry Requirement

• Active Pharmaceutical Ingredients (API) Industry experience is mandatory.
• Experience in Regulatory Affairs functions within pharmaceutical manufacturing organizations.
• Hands-on exposure to DMF and regulatory submissions preferred.

Preferred Candidate Profile

The ideal candidate should possess:

• Strong understanding of API regulatory requirements.
• Knowledge of global pharmaceutical regulations.
• Experience in DMF, CEP, CTD, and eCTD documentation.
• Excellent technical writing and documentation skills.
• Strong communication and coordination abilities.
• Experience working with cross-functional teams.
• Understanding of GMP guidelines and regulatory compliance requirements.

Location & Salary

Location: Boisar, Maharashtra

Approximate Salary: ₹5.5 LPA – ₹9.5 LPA

Actual salary may vary depending on experience, regulatory expertise, current compensation, and interview performance.

Application Process

Interested and eligible candidates can apply by sharing their updated resume through the official company email.

Email Application

Email ID: sonampawar@royalpharma.in

Candidates are advised to mention “Regulatory Affairs Executive (API)” in the email subject line for easier processing.

Documents Recommended

• Updated Resume
• Educational Certificates
• Experience Certificates
• Current CTC Details
• Notice Period Information

Candidates who meet the qualification and experience criteria should apply at the earliest, as hiring may close once suitable profiles are shortlisted.

Why Consider a Career with Royal Pharmaceuticals?

Regulatory Affairs is one of the most important functions in the pharmaceutical industry, particularly in API manufacturing. Professionals working in this field gain exposure to international regulations, product registrations, compliance strategies, and pharmaceutical quality systems.

Benefits of Joining

• Opportunity to work in the growing API pharmaceutical sector.
• Exposure to global regulatory submission processes.
• Experience in DMF, CEP, CTD, and eCTD documentation.
• Cross-functional collaboration with QA, QC, Production, and R&D teams.
• Career growth in pharmaceutical regulatory affairs.
• Exposure to GMP compliance and international regulatory standards.

Frequently Asked Questions (FAQs)

1. What position is available at Royal Pharmaceuticals?

The company is hiring for the position of Regulatory Affairs Executive (API).

2. What qualifications are eligible for this role?

Candidates with B.Pharm, M.Pharm, or M.Sc Chemistry qualifications can apply.

3. How much experience is required?

Applicants should have 3 to 5 years of experience in Regulatory Affairs within the API pharmaceutical industry.

4. Is API industry experience mandatory?

Yes. The company specifically requires candidates with API pharmaceutical industry experience.

5. What regulatory skills are preferred?

Knowledge of DMF, CEP, CTD/eCTD documentation, regulatory submissions, GMP compliance, and dossier preparation is preferred.

6. How can candidates apply?

Interested candidates can send their updated CV to sonampawar@royalpharma.in.

Summary

Category	Details
Company	Royal Pharmaceuticals Industries Pvt. Ltd.
Department Vacancies	Regulatory Affairs Executive (API)
Qualification	B.Pharm, M.Pharm, M.Sc Chemistry
Experience	3 to 5 Years
Location	Boisar, Maharashtra