Senior Specialist, RA OTC
• 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
• 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 3 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 FDA’s 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
• Minimum 3 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 FDA’s 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