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Regulatory Affairs Manager

Regulatory Affairs Manager
Empresa:

Takeda Pharmaceuticals


Detalles de la oferta

Job Description The position is accountable of: Implement all regulatory related activities from the business strategic plan to obtain Marketing Authorizations of New products timely, and guarantee the optimal maintenance of approved portfolio (renewals, variations, etc).
Compliance of regulatory submissions to government agencies for existing and new products.
Participate actively in designated projects, as well as in committees and meetings with government agencies and industry associations.
Oversee compliance o local and global policies related to regulatory processes.
Critical functional knowledge
High level knowledge of local and international regulation (reference countries) for drug products
High level relationships with local HAs and trade associations.
Regulatory strategies development.
Critical business expertise
Minimum prior experience in Regulatory Affairs: 8 years, continuos
Post-graduation / MBA or any other business management related studies is desirable
High level knowledge of pharmaceutical industry
Preferable knowledge in other related areas like finance, Supply, Chain, Marketing, medical affairs and market access.
Solid knowledge of Colombia?s regulatory environment and BoH functions
Minimum proficiency in English: written 100%, listening 80%
Critical technical, professional and personal capabilities
Bachelor in Pharmacist
Advanced-level English
Between 8 to 10 years of work experience in Reg. Affairs.
Solid knowledge of drug products (Biologics and small molecules) and medical devices regulations in Colombia
Competencies based on proactivity, discipline, punctuality, responsibility
Critical leadership capabilities
At least 4 years of work experience as a Manager or team leading.
Multidisciplinary team working experience
Critical thought and problem resolution
Team communication and work
Focused on the customer
Management problem solving skills
Locations
Bogota, Colombia
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time


Fuente: Myjob

Requisitos

Regulatory Affairs Manager
Empresa:

Takeda Pharmaceuticals


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