Company Overview

Covenant Consultants is a distinguished Executive Search and Recruitment Firm headquartered in Chennai, Tamilnadu. With over 350 recruitment specialists, Covenant is committed to delivering timely, high-quality human capital solutions across diverse industries. Driven by principles of integrity and excellence, the firm prides itself on its ability to meet and exceed the needs of clients, candidates, and employees. Our expertise spans IT, Communication, Healthcare, and more.

Job Overview

We are seeking a Senior Regulatory Affairs professional for ANDA Formulation in the US Market. This full-time position is based in Chennai and requires expertise in regulatory submissions and pharmaceutical development. The ideal candidate will have 7 to 10 years of experience in regulatory affairs, with a focus on US market regulations and formulation development, ensuring compliance with FDA guidelines.

Qualifications and Skills

• Minimum 7 years of work experience in regulatory affairs, focusing on ANDA submissions and formulation development for the US market.
• In-depth understanding of regulatory compliance standards and processes in the pharmaceutical industry.
• Experience in ensuring quality assurance through adherence to stringent pharmaceutical regulations.
• Expertise in navigating US market regulations and FDA guidelines.
• Proficient in managing labeling requirements and ensuring product compliance with regulatory standards.
• Must possess strong knowledge of ANDA Submissions (Mandatory skill).
• Must have experience in Formulation Development for the US Market (Mandatory skill).
• Proficiency in US Market Regulations (Mandatory skill).

Roles and Responsibilities

• Develop and execute regulatory strategies for ANDA submissions in the US market, ensuring compliance with all relevant regulations.
• Collaborate with cross-functional teams to guide formulation development and ensure regulatory standards are met throughout the product lifecycle.
• Maintain up-to-date knowledge of FDA guidelines and US market regulations to ensure compliance and successful product approvals.
• Prepare, review, and submit required documentation for regulatory submissions to US FDA and other relevant authorities.
• Implement quality assurance practices to ensure all products meet stringent regulatory requirements.
• Monitor changes in regulatory environments and evaluate potential impacts on existing products and processes.
• Manage labeling requirements and ensure compliance with pharmaceutical regulations.
• Provide expert regulatory advice and support to internal teams and external partners as needed.

Contact Number-9600524854

Email Id-ruskin@covenantindia.net