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Regulatory Affairs / Cosmetics Regulatory / Compliance Regulatory Law / Regulatory Controls

Keywords / Skills : Regulatory Affairs, Registration, CMC Documentation, Form Filling, Biotechnology, Chemistry, Biology, Drug Safety, COSMOS, Cosmetics, Skin Care, Shampoo, Skin, FMCG, Personal Care, Beauty

0 - 4 years
Posted: 2019-03-30

Job Description
Job Responsibilities:

• Draft formats for various applications such like Form 42, Form 43, Form 31, Form 32

• Understanding of BIS & Ingredient analysis as per BIS and drugs & cosmetics act

• Review of documents such as Certificate of analysis, Artwork, FSC and other documents

• Dossier compilation as per the requirement of submission of application

• Understating the regulatory framework and providing regulatory pathway for cosmetic products

• Understating of formats required for filling applications to CDSCO and preparation of the same

• Reviewing data (BMR, MFR, Stability data, specification Data, Label, Process validation, Analytical Method) received from client

• Able to search published literature from Internet.

• Printing & Filing of dossier & data

• Application submission in hard copy or online to CDSCO.

• Troubleshooting and responding to queries raised by Govt. Bodies

B. Pharm/M. Pharm from reputed college

3+ years of experience of similar industry.

Additional Skills Required:

Communication : Good in English communication . Should have good conversational skills

Interpersonal Skills : Excellent Interpersonal skills. Should be able to work with the team, able to communicate effectively with colleagues and clients. Multi tasker, highly motivated, organized and detail oriented individual

About Company

Zoot Systems is a New Delhi, India based company. For years, it has been our continuous endeavors to understand Client quality-conscious discerning business needs and to successfully meet those. We specialize in the creation of high-quality I.T./Non-I.T. based HR Solutions, Recruitment, and RPO to companies of all sizes resulting in better, faster, and more meaningful results. With a focus on state-of-the-art I.T. /Non-I.T. services, Zoot Systems developed a niche and expertise in Staffing, IT Recruiting, Non-IT Recruiting, and Offshore Outsourcing services
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