Job Description

We are hiring !!!

Greetings from Titan Laboratories Pvt Ltd.

We are looking for Sr. Manager / AGM – Regulatory Affairs handling Regulated Market (US, EU, UK, Australia, etc.) in pharma. Details are as below-
·        Experience -15 – 20 years
·        Location – Juinagar, Navi Mumbai
·        CTC is negotiable
·        Education – B.Pharm & M.Pharm

Job description :
·        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.

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.

How to Apply:
Email
your resume to vaibhavi.b@titanpharma.com or call 022-6785 7000 (Ext
725).

Thanks & Regards,
Vaibhavi Behere
HR Department
Titan Laboratories Pvt Ltd