Regulatory Affairs Executive

Detail-oriented Regulatory Affairs Executive responsible for preparing regulatory submissions, maintaining compliance documentation, and supporting product registration activities within pharmaceutical operations. Skilled in dossier compilation, regulatory coordination, document management, and compliance tracking. Experienced in supporting timely approvals, responding to regulatory queries, and ensuring adherence to pharmaceutical regulatory standards.

Roles & Responsibilities

• Prepare and compile regulatory submission documents accurately.
• Support product registration and approval activities.
• Maintain regulatory records, licenses, and submission documentation.
• Coordinate with QA, QC, production, and R&D departments.
• Review labeling, artwork, and packaging documents for compliance.
• Monitor regulatory updates and communicate relevant changes.
• Prepare responses to regulatory queries and deficiency letters.
• Track submission timelines and approval status regularly.
• Ensure compliance with applicable pharmaceutical regulations.
• Maintain regulatory databases and documentation systems.
• Support audit and inspection readiness activities.
• Assist in SOP preparation and compliance documentation.
• Coordinate with external agencies and regulatory consultants when required.
• Ensure proper filing and archival of regulatory documents.
• Contribute to continuous improvement in regulatory affairs processes.

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.