Sr. Manager / AGM Regulatory Affairs -EU/UK- Pharma - Navi Mumbai

Job Description

Dear All,

We are looking for Sr. Manager / AGM - Regulatory Affairs handling Regulated Market(EU, UK, Australia, etc.) in pharma. Details are as below -

• 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

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 candidate can mail their on below contact details -

Contact details -

Mail ID - vaibhavi.b@titanpharma.com

contact - 022 - 6785 7000 (Ext 725).

If you have good references you can share on above details.

Thanks & Regards,

Vaibhavi Behere

HR Department

Titan Laboratories Pvt Ltd.

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