Job
Description
Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP Skin Health Products portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications. Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant critical metrics, particularly in terms of timelines, status of encouraging data required from other functions and dossier preparation. Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies. Keep track of ongoing and outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner. Update and maintain product registration and ingredients archives, databases and tracking tools. Upload and maintain the documentation data as the need arises by the Regional RA team any documentation supporting the placing of the market of other categories of products, such as cosmetics and consumer goods. Work closely with Global and third party business partners to acquire the relevant documents and information for product dossiers. Assist in the preparation of Regulatory Standard Operation Procedures and/or working instruction documents, and in keeping track of revision dates. Assist with the distribution lists of SOPs and the archiving in the documentation system. Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medical devices, cosmetic products, consumer goods). Ensure that the content, organization and overall quality of all regulatory documents are adequate and follows local/regional regulatory requirements, commitments and agreements. Required Qualifications BS degree in Pharmacy or Life Sciences or relevant education. 1+ years of experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries. Understanding of registration and regulatory requirements in various regions. Knowledge of industry practices, techniques and standards. Excellent computer skills, which includes working with Google Suite, electronic databases, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for handling changes and submissions. Fluent in spoken and written English Preferred Qualifications Advanced degree in relevant field Good written and verbal communicator with excellent social skills. Good planning and organizing skills. Ability to work under stress and meet deadlines. Proficient in spoken and written Mandarin and/or other languages
