RA Associate Manager_OTC China
RA Associate Manager_OTC China
Posted on :
23-08-2025
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1 Vacancy
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Job Description
Lead registration operation activities from each OTC RA need state lead from end-to-end
Provide registration operation strategy to OTC RA need state lead
Manage regulatory activities across a designated product range within the OTC portfolio seeking guidance as required
Build strategic regulatory insights into product registration strategies to ensure fast introduction of new products (including new indications) by securing import licences and domestic licences
Proactively partner with internal business stakeholders (local regional global) regional franchise teams and Cross-Sector RA partners to develop of innovative regulatory strategies ensuring that regulatory requirements are incorporated upfront and project risks are understood and mitigations in place.
Develop problem-solving strategies which drive efficiency within the project teams ensure product compliance and deliver high-quality submissions per project timelines for both innovation and Life Cycle management projects (e.g. variations renewals etc.)
Establish and maintain good working relationships with regulatory authorities (Provincial FDA NMPA CDE CFDI institute for drug control etc.) to ensure effective product registrations and represent the company in regulatory industry associations to positively influence the regulatory environment
Monitor the regulatory environment locally and globally and provide timely assessments to business leaders of the impact of new/changing regulations on the current and future pipeline. Provide consultation interpretation and advice to relevant departments to ensure on-time compliance with regulatory guidelines/directives/national requirements
University Degree in Pharmacy Biology Chemistry or related Life Sciences
Minimum 5 years experience in OTC registrations (with thorough understanding of local NMPA regulations) - ability to critically analyse and apply knowledge to develop innovative regulatory strategies.
Multinational company experience and basic understanding of US and EU regulatory framework desired
Developing an external engagement network across NMPA Provincial FDAs and Industry Associations is desired
Ability to operate across a wide range of business activities including in-licencing projects
Ability to work in a matrix organization managing multiple complex projects priorities and systems simultaneously. Able to re-prioritize in an ever-changing environment
Demonstrated leadership and problem-solving skills ability to work independently and seek guidance as needed.
Good interpersonal skills and ability to build effective working relationships at all levels in the organisation
Confident and articulate communicator (both written and verbal) with the ability to convey and present highly complex information to others clearly and logically
Full command of English and relevant local language
Provide registration operation strategy to OTC RA need state lead
Manage regulatory activities across a designated product range within the OTC portfolio seeking guidance as required
Build strategic regulatory insights into product registration strategies to ensure fast introduction of new products (including new indications) by securing import licences and domestic licences
Proactively partner with internal business stakeholders (local regional global) regional franchise teams and Cross-Sector RA partners to develop of innovative regulatory strategies ensuring that regulatory requirements are incorporated upfront and project risks are understood and mitigations in place.
Develop problem-solving strategies which drive efficiency within the project teams ensure product compliance and deliver high-quality submissions per project timelines for both innovation and Life Cycle management projects (e.g. variations renewals etc.)
Establish and maintain good working relationships with regulatory authorities (Provincial FDA NMPA CDE CFDI institute for drug control etc.) to ensure effective product registrations and represent the company in regulatory industry associations to positively influence the regulatory environment
Monitor the regulatory environment locally and globally and provide timely assessments to business leaders of the impact of new/changing regulations on the current and future pipeline. Provide consultation interpretation and advice to relevant departments to ensure on-time compliance with regulatory guidelines/directives/national requirements
University Degree in Pharmacy Biology Chemistry or related Life Sciences
Minimum 5 years experience in OTC registrations (with thorough understanding of local NMPA regulations) - ability to critically analyse and apply knowledge to develop innovative regulatory strategies.
Multinational company experience and basic understanding of US and EU regulatory framework desired
Developing an external engagement network across NMPA Provincial FDAs and Industry Associations is desired
Ability to operate across a wide range of business activities including in-licencing projects
Ability to work in a matrix organization managing multiple complex projects priorities and systems simultaneously. Able to re-prioritize in an ever-changing environment
Demonstrated leadership and problem-solving skills ability to work independently and seek guidance as needed.
Good interpersonal skills and ability to build effective working relationships at all levels in the organisation
Confident and articulate communicator (both written and verbal) with the ability to convey and present highly complex information to others clearly and logically
Full command of English and relevant local language
Required Experience:
Manager
Employment Type
Full Time
Department / Functional Area
Key Skills
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