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Ddreg Pharma
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Isle of Man

Isle of Man

Ddreg Pharma

7 - 10 years

10 - 13 Lacs

gurugram

Posted:11 hours ago| Platform:

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Skills Required

remediation operational excellence french pharma manager regulatory affairs gap analysis document management management microsoft regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

CMC review of technical documentation for regulatory filings to various markets market: US- Gap Analysis and Remediation for module 3 -CMC

Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.

Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.

Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.

Demonstrate subject matter and area expertise.

Collaborate with internal and external clients,

Supporting and enabling effective and efficient communication that results in operational excellence.

Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies website.

Education Experience

Master s degree in Pharma

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years ) or equivalent combination of education, training, experience.

Knowledge, Skills and Abilities

Excellent technical data interpretation skills

Excellent interpersonal skills including problem solving

Excellent oral and written communication skills with strong presentation skills

Significant knowledge of US Regulations

Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Ability and desire to work in a team-oriented environment.

Excellent written and verbal communication skills

Highly proficient with Microsoft Word, PowerPoint and Excel.

Possesses a collaborative, results-driven style.

Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time the incumbent may be required to working slots catering to different time zones

Job Purpose: The Asst. Manager Regulatory Affairs (ASEAN) will lead regulatory strategy, submissions, and compliance for pharmaceutical products intended for the ROW markets. This is an onsite role based in Gurgaon. The individual will serve as a key regulatory liaison, ensuring products meet all regulatory requirements, supporting lifecycle management.

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Isle of Man