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Hector And Streak Consulting
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Dy.Manager Regulatory Affairs - Injectable( US / EU / Canada) , Thane

Dy.Manager Regulatory Affairs - Injectable( US / EU / Canada) , Thane

Hector And Streak Consulting

8 - 10 years

14 - 16 Lacs

Thane

Posted:1 day ago| Platform:

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Skills Required

Dossier Preparation Qbd principles Regulatory affairs Regulatory Compliance Drug Regulatory Affairs USFDA ICH Guidelines MHRA Regulatory Submissions

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Work from Office

Job Type

Full Time

Job Description

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals

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Hector And Streak Consulting

www.hectorandstreakconsulting.com

Consulting

Metropolis

50 Employees

122 Jobs

Key People

John Hector

CEO
Jane Streak

Co-Founder & COO

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Dy.Manager Regulatory Affairs - Injectable( US / EU / Canada) , Thane

Experience & Salary

Skills Required

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Dy.Manager Regulatory Affairs - Injectable( US / EU / Canada) , Thane

Experience & Salary

Skills Required

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Job Description

More Jobs at Hector And Streak Consulting