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The Officer – US Regulatory will be responsible for managing US ANDA filings from new product development (NPD) initiation through to approval. The involvesentifying Reference Listed Drugs (RLDs), reviewing USFDA databases, and coordinating with cross-functional teams including R&D, QA, QC, ADL, SCM, Medical, and PK for dossier preparation. The candidate will handle eCTD compilation, SPL submissions, labeling compliance, regulatory queries, and post-approval activities while ensuring adherence to USFDA guidelines and timelines.
Roles & Responsibilities:
- Manage end-to-end ANDA filing process from NPD initiation to approval.
- Identify suitable RLDs and evaluate product opportunities using USFDA databases.
- Review USFDA guidelines, Orange Book, and other regulatory resources.
- Coordinate with cross-functional teams (R&D, QA, QC, ADL, SCM, Medical, PK) for dossier preparation.
- Compile and submit eCTD dossiers in compliance with USFDA requirements.
- Prepare and manage Structured Product Labeling (SPL) submissions.
- Ensure accuracy and compliance of labeling, artwork, and packaging components.
- Handle regulatory queries, deficiency letters, and information requests from USFDA.
- Manage post-submission activities including amendments, variations, and supplements.
- Prepare and submit annual reports and other regulatory commitments.
- Track submission timelines and ensure adherence to regulatory deadlines.
- Maintain regulatory documentation, records, and submission archives.
- Review technical documents for completeness, accuracy, and compliance.
- Coordinate bioequivalence (BE) and pharmacokinetic (PK) study documentation as required.
- Support lifecycle management activities for approved products.
- Monitor regulatory updates, guidance documents, and industry trends.
- Ensure compliance with data integrity and documentation standards.
- Collaborate with artwork and packaging teams to ensure regulatory compliance.
- Participate in audits, inspections, and regulatory reviews.
- Provide regulatory support for new product development and portfolio expansion.
- Prepare MIS reports and status updates for management review.
- Maintain confidentiality and adherence to company policies and regulatory standards.
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About Medley Pharmaceuticals Ltd
Medley Pharmaceuticals Ltd is a pharmaceutical company engaged in the development, manufacturing, and marketing of a wide range of pharmaceutical products.
The company focuses on delivering quality-driven and affordable medicines to meet the evolving healthcare needs of patients and medical professionals.
Our Story
Medley Pharmaceuticals Ltd was established with a vision to provide reliable and effective pharmaceutical solutions.
Over the years, the company has expanded its presence across domestic and international markets, building a reputation for quality, consistency, and trust in the pharmaceutical industry.
Our Mission
The company is committed to:
- Delivering high-quality and affordable pharmaceutical products
- Ensuring strict adherence to regulatory and quality standards
- Expanding access to essential medicines across markets
- Continuously improving processes and product offerings
Our Vision
To be a globally recognized pharmaceutical company known for quality, innovation, and excellence in healthcare solutions.
Our Services / What We Offer
Medley Pharmaceuticals Ltd offers a diverse portfolio of pharmaceutical products and solutions, including:
- Development and manufacturing of pharmaceutical formulations
- Marketing and distribution of medicines
- Therapeutic solutions across multiple healthcare segments
- Focus on quality assurance and regulatory compliance
Why Choose Us
The company stands out for its commitment to excellence:
- Strong focus on quality and compliance
- Established presence in domestic and international markets
- Experienced team and industry expertise
- Commitment to affordability and accessibility
- Continuous improvement in products and processes
Our Team
Medley Pharmaceuticals Ltd is supported by a team of professionals dedicated to maintaining high standards in manufacturing, quality control, and operations.
Their expertise ensures consistent delivery of reliable pharmaceutical products.
Infrastructure / Technology
The company utilizes modern manufacturing facilities and advanced technologies to ensure the production of high-quality medicines.
Its infrastructure is designed to meet regulatory requirements and support efficient operations.
Our Commitment
Medley Pharmaceuticals Ltd remains committed to delivering safe, effective, and high-quality pharmaceutical products while maintaining strong ethical standards.
The company continuously works towards innovation, quality enhancement, and improved healthcare outcomes.
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