Regulatory Affairs Manager

About Esmero Research Pvt. Ltd. Based in Ahmedabad, Gujarat, India, Esmero Research Pvt. Ltd. is a reputable pharmaceutical firm that was founded in 2017. With a broad range of products, including tablets, capsules, injectables, ointments, and topical treatments, Esmero is a pharmaceutical manufacturing, marketing, and exporting company. Dedicated to providing high-quality, reasonably priced medications to enhance world health, Esmero operates a state-of-the-art WHO-GMP-certified facility in Uttarakhand and strictly adheres to cGMP and ISO standards. The business continues to spur innovation and expansion in the pharmaceutical industry while maintaining a robust global presence and providing regulatory support and adaptable trade models.

What You’ll Do As a Regulatory Affairs Manager, you will lead the regulatory team and oversee all regulatory submissions, compliance, and product registrations for various international and domestic markets. You will play a key role in strategizing and ensuring timely approvals, while also managing cross-functional collaborations with internal and external stakeholders.

Your Key Responsibilities

● Dossier Preparation & Compilation: Lead and oversee the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring compliance with country-specific guidelines.

● Regulatory Strategy & Market Compliance: Develop and execute regulatory strategies for product approvals in the ROW, LATAM, SEA, Africa, and Pacific regions.

● Bioequivalence Studies & Compliance: Ensure compliance with bioequivalence study requirements for international submissions and coordinate with CROs for study approvals.

● Product Lifecycle Management: Manage regulatory aspects throughout the product lifecycle, including renewals, variations, and post-marketing compliance.

● Product Registration & Market Expansion: Handle product registration processes, liaising with regulatory authorities and ensuring smooth approvals in targeted markets.

● Technical File Review: Ensure accuracy and completeness of technical files for regulatory submissions.

● Regulatory Compliance & Audits: Monitor and ensure compliance with country-specific regulatory guidelines, including WHO-GMP, ICH, and other applicable standards.

● Regulatory Documentation & Reporting: Maintain up-to-date regulatory documentation and provide periodic reports to senior management.

● Stakeholder Management: Serve as the primary liaison between regulatory agencies, internal teams, and external partners to facilitate submissions and approvals.

● Process Improvement & Team Leadership: Implement process improvements, mentor junior regulatory staff, and drive efficiency in regulatory operations.

What Makes You a Fit

Academic Background:

● A Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.

Skills and Experience:

● 7-+ years of experience in Regulatory Affairs within the pharmaceutical industry.

● In-depth knowledge of CTD, ACTD, eCTD dossier compilation, and regulatory submission processes.

● Experience in handling bioequivalence studies and related regulatory documentation.

● Experience in preparing parenteral dossiers will be an added advantage.

● Strong understanding of global regulatory requirements and product lifecycle management.

● Expertise in coordinating with regulatory agencies, health authorities, and international clients.

● Excellent communication, leadership, and problem-solving skills.

● Proficiency in MS Office (Word, Excel, PowerPoint) for documentation and reporting.

Why You’ll Love It Here

● Leadership Role in Regulatory Affairs: Drive regulatory strategy and compliance for a leading pharmaceutical company.

● Career Growth & Learning: Work in a dynamic environment with opportunities for professional development and leadership advancement.

● Competitive Compensation: Offering a comprehensive salary package that reflects your expertise and contributions.

● Collaborative Work Culture: Engage with cross-functional teams to ensure smooth regulatory operations.

● Work-Life Balance: A structured work environment promoting professional and personal growth.

Join Us

This role is based in Ahmedabad, India, a major hub for pharmaceutical innovation. As a Regulatory Affairs Manager, you will play a critical role in ensuring regulatory excellence, product approvals, and business growth. This is your opportunity to contribute to a company that values precision, compliance, and international expansion.

Job Type: Full-time

Pay: ₹35,000.00 - ₹50,000.00 per month

Benefits:
• Cell phone reimbursement

Schedule:
• Day shift

Supplemental Pay:
• Yearly bonus

Experience:
• total work: 4 years (Preferred)

Work Location: In person