Required Senior Executive Regulatory Affairs & License
Roles and Responsibilities
- Ensuring compliance with regulations set by medicines and healthcare products
regulatory agency namely (AYUSH, FSSAI, DRUG and COSMETIC ACT).
- Should have knowledge / Experience with EU, UK, USA, Australia, Africa regulations
- Keeping up to date with changes in regulatory legislation and guidelines
- Offering advice about company policies, practices and system
- Outlining requirements for labeling, storage and packaging
- Keeping a check on label content and leaflets as per regulatory norms (Label proofing &
Artwork)
- Obtaining market permissions and approvals for company distributers as per regulatory
laws if any
- Liaising and negotiating with regulatory authorities
- Ensuring that quality standards are met and submission meet strict deadlines with proper
documentation
- Full knowledge of company products and related laws
- Filling of application and submission legal documents under various acts (AYUSH, FSSAI
AND DRUG & COSMETIC ACT)
- Planning, undertaking and overseeing product trials and regulatory inspections
- Analyzing complicated information, including trial data
- Providing advice about regulations to manufacturers/scientists.
- Prepare submissions of license variations and renewals to strict deadlines
- Monitor and set timelines for license variations and renewal approvals
Desired Candidate Profile
Experience: 5 to 7 Year
INDUSTRY: Ayurvedic/Cosmetic
SPECIALIZATION: Drug Regulation
QUALIFICATION: M.Sc/B.Tech/M.Tech
Role:Regulatory Affairs Manager
Salary: Not Disclosed by Recruiter
Industry:FMCG, Foods, Beverage
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Employment Type:Full Time, Permanent
Education-
UG:
PG:M.Tech in Chemical,MS/M.Sc(Science) in Chemistry
Doctorate:
Company Profile
CHOLAYIL PVT LTD
Cholayil was stared in 1969 by Dr. Sidhan, a certified medical professional. Dr. Sidhan used his understanding of Ayurveda to develop Medimix, ayurveda soap. Medimix soon became a household name and also transformed into the flagship brand of the company. The ingredients in Medimix are frequently used in Ayurveda for the treatment of skin maladies. The quality of the product and marketing perseverance of Dr. Sidhan were crucial factors for the success of the Medimix Brand.
In 2011, the leadership of the company passed on to Mr. V. S. Pradeep Cholayil and now it has become a multi Crore FMCG organization. In 2007, Cholayil acquired the talcum powder brand Cuticura and expanded it to the deodorant and soap segments. It also acquired the soap brand Krishna Thulasi in 2011. Cholayil’ s other subsidiaries are Sadayush, an Ayurvedic cure and care center, and Jullaaha, a clothing line made from natural dyes and fibers.
Our company website: www.Cholayil.com
Company Info
View Contact Details+
Contact Company:CHOLAYIL PVT LTD
Address:NO-08,J BLOCK, 6TH AVENUE,ANNA NAGAR EAST, Chennai, Tamilnadu, India