Regulatory Affairs - Regulated Market - Pharma - Navi Mumbai

• Responsible for overseeing al aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market.
• Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies.
• Leading the preparation and submission of regulatory dossiers to health authorities for new drug applications, variations, renewals, and post-market surveillance reports.
• Ensuring adherence to all applicable regulatory requirements, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and labelling regulations.
• Building and maintaining strong relationships with regulatory agencies, proactively addressing any concerns or queries regarding product submissions.
• Managing and developing a team of regulatory professionals, including regulatory affairs managers, specialists, and associates, ensuring their expertise is utilized effectively.

Education: B Pharm/M Pharm with exposure in Regulatory Affairs for 15 to 20 years in pharma.

Desirable Skills & Competencies:

• Deep understanding of global pharmaceutical regulations, including ICH guidelines and relevant regional regulations.
• Extensive experience in the drug development process, from pre-clinical to post-market surveillance.
• Proven leadership skills in managing and motivating a regulatory affairs team.
• Excellent communication, negotiation, and interpersonal skills to effectively interact with regulatory agencies and internal Stakeholders.

Interested candidates can mail their updated resume & CTC on sumit.s@titanpharma.com.

Thanks & Regards,

Sumit Shirke

HR Department

Titan Laboratories Pvt Ltd