Experience: 4 to 8 yrs.
Candidate will be responsible to Lead or provide assistance for regulatory projects at international level, such as the preparation of registration and reimbursement documents, preparation of scientific advice.
Act as the main contact person between the overseas distributor and Silom Medicals quality assurance team.
Develop and execute regulatory plans for complex projects including new products, sourcing projects and maintenance of licenses/authorizations for existing marketing authorizations.
Monitor applicable regulatory requirements; assure compliance with Silom Medical International and external standards.
May review promotional material or SOPs for compliance with local and global regulations.
Perform annual supplier audit overseas.
Candidate should have at least 4 years of experience in international regulatory affairs for a multinational generics pharmaceutical company.
Should have experience in reviewing the Dossier under CTD (European) guidelines for finished formulations.
Good interpersonal and negotiation skills.
Ability to manage complex projects and timelines.
Ability to lead and coach others.
High level of organization and commitment with a strong attention to details.
Should be ready to relocate at Bangkok, Thailand.
Candidate will be responsible to Lead or provide assistance for regulatory projects at international level, such as the preparation of registration and reimbursement documents, preparation of scientific advice.
Act as the main contact person between the overseas distributor and Silom Medicals quality assurance team.
Develop and execute regulatory plans for complex projects including new products, sourcing projects and maintenance of licenses/authorizations for existing marketing authorizations.
Monitor applicable regulatory requirements; assure compliance with Silom Medical International and external standards.
May review promotional material or SOPs for compliance with local and global regulations.
Perform annual supplier audit overseas.
Candidate should have at least 4 years of experience in international regulatory affairs for a multinational generics pharmaceutical company.
Should have experience in reviewing the Dossier under CTD (European) guidelines for finished formulations.
Good interpersonal and negotiation skills.
Ability to manage complex projects and timelines.
Ability to lead and coach others.
High level of organization and commitment with a strong attention to details.
Should be ready to relocate at Bangkok, Thailand.
Contact Details
Recruiter Name:
Sandeep Tyagi
Telephone:
0120-3070943
Reference Id:
sandeep.tyagi@naukri.com
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