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Assistant Manager- Regulatory Affairs (Pharma) - Pune

5 - 8 years

0 Lacs

Pune

Posted:3 weeks ago| Platform: Naukri logo

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Skills Required

Regulatory Affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

About Us : Sydler Group of Companies is a leading manufacturer and exporter of excellent quality and reliable Pharmaceutical Formulations, Herbal formulations, Nutraceuticals & Dietary Supplements, and Nutritional food products, catering to discerning market needs globally. Ever since its inception in 2004, we have set new benchmarks in the arena of herbal products manufacturing, leveraging state-of-the-art infrastructure, skilled professionals, and uncompromised commitment towards quality and innovation. Role : Assistant Manager - Regulatory Affairs (Pharma Experience Mandatory) Responsibilities : Responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions -Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets. -Works with other functional areas to resolve issues related to information for regulatory submissions. -Evaluate, prepare and review of post approval supplements to manage the regulatory product life cycle as applicable. -Review of change control documents. -Participation in meetings with the R&D and Business development for the new product -Coordination with the manufacturing locations for obtaining the CMC data for the regulatory applications. -To check the artworks for compliance with regulatory and pharmacopeia requirements of products •Well versed of ICH Guidelines -Leadership & Teamwork Knowledge Well versed with CTD, ACTD, Country specification requirements for ROW, LATAM, ASEAN, CIS, MENA Region ,Knowledge about ICH Guidelines Skill Team work , Leadership, Time management alongwith team building , Analytical and problem solving skills, Presentation Skills, Interpersonal skills. Communication skills.

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Sydler Remedies
Sydler Remedies
www.sydlerremedies.com

Pharmaceuticals

Helsinki

50 Employees

3 Jobs

    Key People

  • John Doe

    CEO

  • Jane Smith

    CTO

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