Descripción del puesto:
Working closely with our Headquarters team and reporting directly to Regulatory Affairs Manager in China, you will support the local development and implementation of the regulatory strategy and obtain / maintain marketing authorizations (MAs) of all medicinal products, cosmetics and medical devices registered/commercialized by (COMPANY NAME)/POLICHEM in China ensuring that legislative requirements are met.
Tasks and Responsibilities
* Support in the development and implementation of regulatory strategy and keep up to date with changes in regulatory legislation and guidelines.
* Ensuring compliance with regulations set by the CFDA/CDE and other Chinese regulatory bodies
* Support the planning, undertaking and overseeing product trials and regulatory inspections
* Help to supervise activities carried out for regulatory purposes through consultants, CROs, local agents and partners.
* preparing and assembling a regulatory file/dossier and follow-up of a regulatory file
* participate as an expert in regulatory matters in meetings with other departments, external companies and health authorities and also providing advice about regulations to manufacturers/scientists
* obtaining marketing permission reporting on the regulatory databases all relevant information and associated documents, also informing the organization as per internal procedure to ensure implementation of regulatory changes.
* regulatory monitoring of approved products, such as writing, revising and approving product information and finished-product documentation, reviewing promotional materials for compliance, maintaining the registration licenses, submitting annual notification of changes, collecting and analyzing the effects of a change, properly notifying authorities about changes and their implementation, properly managing post-approval commitments plans
* outlining requirements for labelling, storage and packaging
* ensuring that quality standards are met and submissions meet strict deadlines
* studying scientific and legal documents
* Development of a both significant and fertile network of relations with regulatory authorities and the medical/scientific world.
* Further relational development within the group, so as to achieve cross-fertilization of management, performance, and best practices at large.
* help to improve company procedures and day to day operation
* Support the assessment and business plan long-term preparation for China, considering current portfolio and (COMPANY NAME)'s pipeline
* Relevant degree such as chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science or applied science.
* A relevant postgraduate qualification (PhD or research-based MSc) may be advantageous.
* Postdoctoral research, practical research or laboratory work experience is also beneficial. Regulatory affairs experience is particularly sought after.
* Key skills for this position: IT, negotiation, analytical, time management, problem-solving, presentation, interpersonal and communication skills.
* An understanding and appreciation of relevant legal, scientific, Quality Assurance and manufacturing areas is also necessary.
* 5-7 year's prior experience in the pharma industry
* Chinese, English (high level) and other languages is particularly sought after.
Values and competencies