Regulatory Affairs Manager in Multinational Pharmaceutical Company
Multinational Pharmaceutical Company(MNC) is wholly owned sales subsidiary in United Kingdom of Intas Pharmaceuticals Ltd. India which is having 1.3 billion USD sales revenue and more than 20 sales subsidiaries and representative offices across world including US, Canada, UK, Spain, France, Australia, Dubai, South Africa, Brazil, Mexico etc… MNC is having more than 150 pharmaceutical molecules approved in Europe in various therapies including Oncology, Cardio-Vascular, Nephrology, Gastro-intestinal, Central Nervous System, Auto-immune diseases. And also selling more than 30 pharmaceutical products in US.
As part of expansion in Asian markets, MNC would like to start subsidiary and office in South Korea to manage regulatory, sales and business development activities for it’s pharmaceutical products approved in EU and US markets and manufactured in state-of-art sites having US-FDA, MHRA-UK, TGA-Australia cGMP certifications.
For the same, MNC is looking for a suitable candidate to manage regulatory activities with MFDS-Korea in South Korea.
Regulatory Affairs Manager
Direct report: Regional Business Head - North Asia
Functional Reporting: Regional Regulatory Manager - APAC
- At least 8 to 10 years professional experience in managing ethical pharmaceutical products (generics) regulatory / registration activities with MFDS-Korea.
- Must be License Pharmacist
Seoul, South Korea
Portfolio of Pharmaceutical generic molecules (Oncology & Non-Oncology)
• Compilation and preparation of dossiers as per local South Korea Pharmaceutical regulatory – MFDS requirement.
• Submission and co-ordination with MFDS-South Korea and with regulatory / technical team at head quarter.
• Incase of requirement of doing local pharmaco-equivalence for injectable products, finding out and co-ordinating with local laboratory for performing it.
• Incase of local BE requirement for oral products, finding out suitable CRO and co-ordinating with local CRO and HO regulatory team.
• To support and coordinate between MFDS and Plant site for Site Inspection, if required.
• Prepare a regulatory plan for submissions and renewals and ensure implementation as per agreed timelines.
• Coordinate with the Regulatory Head Quarter (RA HO) & Regional RA Manager for query replies an all product submission status.
• Provides up to date Registration status and estimated timeline for submission/ MA Approval.
• Proactively provides input on the current and upcoming New Regulation/Guideline and assess possible impact to registered/ upcoming registration product.
• Responsible for all Pharmacovigilance / Quality Complaint Report to be reported to RA / QA Head quarter.
• Supporting administrative role (if whenever necessary) for subsidiary operations in South Korea.
• Atleast of 8 to 10 years professional experience in regulatory activities with MFDS including dossier submission.
• Should have worked in good local Korean companies.
• Fluent in English (Reading, writing and speaking).
• Good communicator with consultative style, multi-tasting abilities and efficient co-ordination with cross functional team.
• Should have a sound knowledge of and clarity of Pharmacology / Pharmacy & Therapeutic Segments of the products.
• At least Pharmacy graduate from South Korea’s reputable university.
Should be proficient in English & Korean Local Language
[Reasons for Recruitment]
New start up
[Number of Persons] 1
[Foreign Languages] English
[Apply a Position]
Please send your English resume(Documents/ CVs must be written in English)A.S.A.P (MS word only)by E-mail firstname.lastname@example.org
* The title of E-mail should be Regulatory Affairs Manager in Multinational Pharmaceutical Company
* All submitted documents will be treated with highly confidential manner.
Thank you for your interest.
Tel No 82-2-555-7234
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