Key Job Responsibilities:
? Take active role to build regulatory intelligence for Process Solution.Focused area include Single Use as top priority, and will also cover AsepticProcessing, Virus Validation and process materials.
? Drive thought leadership initiatives and build up relationship and advocacywith local authorities and industry associations in terms of Process Solutionsinterests.
? Safeguard Process Solution strategic interests and objectives in arisingguidance, standards and regulation.
? Monitor and report on changes of relevant regulatory and complianceenvironment with impact with Process Solution business. Analyze availableregulatory and compliance information.
? Increases the influence of Company in important regulatory bodies andindustry associations.
? Actively participates and represents Life Science - Process Solution inrelevant industry associations.
? Effective coordination of strategic activities of Process Solution subjectmatter experts in local regulatory bodies and industry associations.
? Secure flow of information from/to authorities, industry associations andProcess Solution organization.
? Builds and keeps personal relationships to local and national authorities.
? Coordinates processes with internal functions for the commenting/drafting ofregulatory/industry guidelines, regulations and standards.
? Training for and support of internal stakeholders, external customers andrelevant regulatory bodies.
? Provide relevant training to educate local Process Solution marketing/salescolleagues about new regulatory trends and developments that drive our valueproposition.
? Builds processes for the flow of information and regulatory intelligencewithin Process Solution organization APAC.
? Definition of processes to implement upcoming regulatory needs andrequirements.
? Support regulatory expertise and consultation for customer regulatoryinquiries.
? Closely work with global regulatory surveillance & advocacy team andProcess Solution regulatory subject matter experts to link the local advocacyactivities with global advocacy activities.
? Monitor competitor approach regarding regulatory requirements.
Education and Languages:
? Master / Ph.D. in life sciences or related science/engineering background witha strong emphasis in biologics.
? Fluent in Chinese & English (verbal and written) is required.
Professional Skills and Experiences:
? Minimum of 3 to 5 years of relevant industry experience and/or regulatoryaffairs related to biopharmaceutical products, pharmaceutical substances andprocess materials.
? Knowledgeable of CFDA drug regulations and regulatory landscape of otherimportant country/regions (eg. China, Japan, South Korea, EU, US)
? Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory andcompliance requirements, aseptic processing and validation procedures.
? Knowledge of regulations for Advanced Therapeutic Medicinal Products (cell,gene therapy).
? Knowledge/experience for regulations concerning complex biologics (i.e., monoclonalantibodies and recombinant proteins) expressed in mammalian cell culture.
? Experience working in a global, matrix environment.
Personal Skills and Competencies:
? Strong organizational and time management skills.
? Good project management skills.
? Ability to train and educate others.
? Effective management by influence.
? Some experience in thought leadership.
? Ability to work in multi-cultural teams.
? Good listening skills with the ability to analyze and respond to givensituations quickly and effectively.
? Excellent interpersonal, presentation, listening and communication skillsthat will develop long term internal and external relationships at all levels.
? Ability to indirectly influence other organizations and cultures.
? Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
? Able and willing to travel frequently