Regulatory Affairs Manager

Experienced Regulatory Affairs Manager responsible for managing pharmaceutical regulatory submissions, product registrations, compliance documentation, and regulatory strategy across domestic and international markets. Skilled in dossier preparation, regulatory approvals, authority coordination, lifecycle management, and cross-functional compliance. Adept at ensuring timely approvals, regulatory readiness, and adherence to pharmaceutical guidelines while supporting business growth and product expansion.

Roles & Responsibilities

• Manage end-to-end regulatory affairs and product registration activities.
• Prepare, review, and submit regulatory dossiers accurately.
• Ensure compliance with domestic and international regulatory guidelines.
• Coordinate with regulatory authorities for approvals and submissions.
• Review product labeling, artwork, and packaging compliance requirements.
• Monitor changes in regulatory policies and industry guidelines.
• Coordinate with QA, QC, production, and R&D teams for submissions.
• Handle regulatory queries and deficiency response activities.
• Maintain licenses, approvals, and regulatory documentation systematically.
• Develop regulatory strategies for product lifecycle management.
• Track submission timelines and ensure timely regulatory filings.
• Support audits and regulatory inspection readiness activities.
• Train teams on regulatory compliance and documentation practices.
• Maintain confidentiality and accuracy of regulatory information.
• Support market expansion through timely regulatory approvals.

Olive PharmaScience Ltd is a research-driven pharmaceutical manufacturing company specializing in the development and production of customized pharmaceutical formulations, over-the-counter (OTC) products, dietary supplements, and soft gelatin dosage forms. With a strong focus on innovation, quality, and global healthcare needs, the company serves pharmaceutical partners and healthcare markets across the world.

As a fully integrated pharmaceutical organization, Olive PharmaScience combines advanced manufacturing capabilities, scientific expertise, and regulatory excellence to deliver high-quality healthcare solutions that improve patient outcomes and support global wellness initiatives.

Our Story

For more than five decades, Olive PharmaScience has been dedicated to advancing pharmaceutical innovation through the development of specialized formulations and healthcare products. The company has built its reputation on a commitment to quality, scientific excellence, and customer-focused manufacturing solutions.

Over the years, Olive PharmaScience has expanded its capabilities through investments in research, advanced manufacturing technologies, and international regulatory compliance. Today, the company is recognized for its expertise in soft gelatin formulations and its ability to deliver customized pharmaceutical solutions for global healthcare markets.

Our Mission

To develop and manufacture innovative, high-quality pharmaceutical and healthcare products that enhance patient well-being and support better healthcare outcomes worldwide.

Key mission priorities include:

Delivering high-quality pharmaceutical formulationsAdvancing innovation through scientific researchSupporting global healthcare accessibilityMaintaining stringent quality and compliance standardsBuilding long-term partnerships with healthcare organizationsEnhancing patient care through effective dosage technologiesOur Vision

To be a trusted global pharmaceutical partner recognized for innovation, quality, scientific excellence, and advanced healthcare solutions that improve lives worldwide.

Our Services / What We Offer

Olive PharmaScience offers a comprehensive range of pharmaceutical development and manufacturing services, including:

Soft Gelatin Capsule ManufacturingPharmaceutical Formulation DevelopmentCustomized Pharmaceutical ProductsOver-the-Counter (OTC) ProductsDietary SupplementsNutraceutical ProductsContract Development and Manufacturing Services (CDMO)Product Licensing SolutionsRegulatory Support ServicesGlobal Pharmaceutical Supply Solutions

The company serves diverse healthcare categories, including:

Generic PharmaceuticalsOTC Healthcare ProductsNutritional SupplementsHigh-Potency MoleculesHormonal ProductsOncology ProductsImmunosuppressants

Why Choose UsMore than five decades of pharmaceutical expertiseSpecialized focus on soft gelatin dosage formsFully integrated pharmaceutical manufacturing capabilitiesStrong research and development infrastructureInternational regulatory approvals and certificationsGlobal market presence and partnershipsCustomized product development solutionsCommitment to quality, innovation, and complianceAdvanced manufacturing technologiesCustomer-centric approach to pharmaceutical development

Our Team

Olive PharmaScience is supported by a team of pharmaceutical scientists, researchers, quality specialists, regulatory professionals, manufacturing experts, and business leaders who work together to deliver innovative healthcare solutions.

The organization promotes a culture of continuous learning, scientific excellence, collaboration, and innovation, enabling teams to address evolving healthcare challenges and market requirements effectively.

Infrastructure / Technology

Olive PharmaScience operates three state-of-the-art manufacturing facilities in India designed to meet international current Good Manufacturing Practice (cGMP) standards. These facilities support large-scale pharmaceutical manufacturing while ensuring quality, efficiency, and regulatory compliance.

Key infrastructure strengths include:

Soft Gelatin Manufacturing FacilitiesPharmaceutical Development LaboratoriesResearch and Development CentersQuality Control LaboratoriesAdvanced Analytical SystemsRegulatory Documentation SupportInternational Supply Chain CapabilitiesScalable Manufacturing Infrastructure

The company is also expanding its capabilities with GMP-approved gummy manufacturing facilities for nutritional and pharmaceutical OTC products.

Quality & Compliance

Quality remains a cornerstone of Olive PharmaScience's operations. The company follows stringent manufacturing, testing, and quality assurance practices to ensure product safety, efficacy, and consistency.

Its regulatory approvals and certifications include:

US FDAWHO-GMPEU GMPTGA AustraliaRegulatory approvals across multiple international markets

These standards support the company's ability to serve highly regulated pharmaceutical markets worldwide.

Research & Innovation

Innovation is central to Olive PharmaScience's growth strategy. The company focuses on transforming traditional oral dosage forms into advanced soft gelatin formulations that improve bioavailability, patient compliance, and therapeutic effectiveness.

Through continuous investment in research and product development, Olive PharmaScience strives to create differentiated healthcare solutions that meet the evolving needs of patients and healthcare providers globally.

Our Commitment

Olive PharmaScience is committed to improving healthcare through scientific innovation, manufacturing excellence, and responsible business practices. The company continuously invests in technology, quality systems, and talent development to ensure reliable healthcare solutions for global markets.

Guided by its commitment to quality, innovation, and patient well-being, Olive PharmaScience aims to build lasting partnerships while contributing to a healthier future for communities around the world.