manager Regulatory Affairs- apac region (remote, philippines)PharmaLex
Workplace: MetroManila, Manila, Makati
Salary: Agreement
Work form: Full time
Posting Date: 19/11/2023
Deadline: 15/11/2022
Manager Regulatory Affairs- APAC Region (Remote, Philippines)
Your Job
Participation in regulatory processes to gain and maintain APAC and non-APAC marketing authorizations for human and veterinary medicinal products (application, renewal, variations)
General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labeling
Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labeling)
Presenting seminars and lectures PharmaLex-internally, for customers and for professional audience
Responsible for the planning, filing and prosecution of approval projects.
Creation, revision, editing and maintenance of regulatory documentation.
Planning and expediting the approval projects using the internally available or client-based software tools (Veeva Vault).
Communication with the client and the Health Authorities (APAC region).
Coordination of project teams with internal and external staff and RegNet Partners.
Contribution to optimizing departmental internal/clients processes.
Active contribution and distribution of department relevant expertise.
If applicable support in preparation, quotation and invoicing for Regulatory Affairs Projects in close cooperation with the respective Team Lead
Your Profile
University degree in pharmacy or other natural sciences preferably in Pharmacy/Chemistry/Microbiology and Biochemistry
Proven experience (+4 years) in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on quality aspects
Leadership experience with minimum 2-3 direct reports
Ability to implement tactical goals of customer or internal projects within daily work
Structured, analytical, systematic and independent manner
Resourceful, solution-oriented and get-goer attitude
Capability of supervision, prioritization and processing of parallel projects and tasks
High service orientation
Ability to manage internal and external (client) relationships on operational as well as client's team lead level
Excellent team player
Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
English language fluency, written and spoken
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PharmaLex
Your Job
Participation in regulatory processes to gain and maintain APAC and non-APAC marketing authorizations for human and veterinary medicinal products (application, renewal, variations)
General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labeling
Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labeling)
Presenting seminars and lectures PharmaLex-internally, for customers and for professional audience
Responsible for the planning, filing and prosecution of approval projects.
Creation, revision, editing and maintenance of regulatory documentation.
Planning and expediting the approval projects using the internally available or client-based software tools (Veeva Vault).
Communication with the client and the Health Authorities (APAC region).
Coordination of project teams with internal and external staff and RegNet Partners.
Contribution to optimizing departmental internal/clients processes.
Active contribution and distribution of department relevant expertise.
If applicable support in preparation, quotation and invoicing for Regulatory Affairs Projects in close cooperation with the respective Team Lead
Your Profile
University degree in pharmacy or other natural sciences preferably in Pharmacy/Chemistry/Microbiology and Biochemistry
Proven experience (+4 years) in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on quality aspects
Leadership experience with minimum 2-3 direct reports
Ability to implement tactical goals of customer or internal projects within daily work
Structured, analytical, systematic and independent manner
Resourceful, solution-oriented and get-goer attitude
Capability of supervision, prioritization and processing of parallel projects and tasks
High service orientation
Ability to manage internal and external (client) relationships on operational as well as client's team lead level
Excellent team player
Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
English language fluency, written and spoken
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PharmaLex
Other Info
Makati City, Metro Manila
Permanent
Full-time
Permanent
Full-time
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PharmaLex
About the company
Position manager Regulatory Affairs- apac region (remote, philippines) recruited by the company PharmaLex at MetroManila, Manila, Makati, Joboko automatically collects the salary of , finds more jobs on Manager Regulatory Affairs- APAC Region (Remote, Philippines) or PharmaLex company in the links above
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