Opening for Trainee Drug Regulatory Affairs/Documentation @ Daewoong Pharmaceutical Co. Ltd.
Job Description
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1. To prepare the documents required to obtain drug license/marketing authorization in India, US and EU markets.
2. Handling of licenses, like Test license, Import license, Manufacturing license, Loan Licenses and Export license etc..
3. To coordinate with manufacturing unit and prepare relevant documents essential for registration of Pharmaceutical products.
4. Assisting in the compilation of various regulatory submissions of domestic and International regulatory agencies.
5. Interacting with various departments like QC, QA, R&D, Production for required documents for the compilation of registration of Pharmaceutical products.
6. Knowledge on ICH guidelines, Guidelines and Acts of other regulatory agencies like US FDA, EMA, CDSCO etc
7. Collect, compile and maintain the regulatory guidelines from various regulatory authorities and continuous checking for any updates in regulations.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Keyskills
Regulatory Affairs
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy, M.Sc - Any Specialization
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
1. Must be Proficient in written, verbal, Computer skills and business communication.
2. Should be self motivated and result oriented.
3. Should be keen learner, proactive and good analytical skills.
4. Ability to Multitask and prioritize responsibilities.
5. M. Pharm. or M.Sc.
Company Profile:
Daewoong Pharmaceutical Co. Ltd.
Established in 1945, Daewoong Pharmaceutical Co., Ltd. has the largest prescription drug sales in Korea and have presence in 9 countries, we are developing product for US & Europe market.
Click here to apply
Job Description
Send me Jobs like this
1. To prepare the documents required to obtain drug license/marketing authorization in India, US and EU markets.
2. Handling of licenses, like Test license, Import license, Manufacturing license, Loan Licenses and Export license etc..
3. To coordinate with manufacturing unit and prepare relevant documents essential for registration of Pharmaceutical products.
4. Assisting in the compilation of various regulatory submissions of domestic and International regulatory agencies.
5. Interacting with various departments like QC, QA, R&D, Production for required documents for the compilation of registration of Pharmaceutical products.
6. Knowledge on ICH guidelines, Guidelines and Acts of other regulatory agencies like US FDA, EMA, CDSCO etc
7. Collect, compile and maintain the regulatory guidelines from various regulatory authorities and continuous checking for any updates in regulations.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Keyskills
Regulatory Affairs
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy, M.Sc - Any Specialization
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
1. Must be Proficient in written, verbal, Computer skills and business communication.
2. Should be self motivated and result oriented.
3. Should be keen learner, proactive and good analytical skills.
4. Ability to Multitask and prioritize responsibilities.
5. M. Pharm. or M.Sc.
Company Profile:
Daewoong Pharmaceutical Co. Ltd.
Established in 1945, Daewoong Pharmaceutical Co., Ltd. has the largest prescription drug sales in Korea and have presence in 9 countries, we are developing product for US & Europe market.
Click here to apply
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