Ref #: 27323

Employment type: Permanent - Full-Time

Location: China-Beijing

Posted: 02-Mar-2021


As a Regulatory Affairs Specialist (RA) you will be accountable for implementing regulatory strategy to obtain the regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product group.
Support line-manager on the regulatory strategy assessment and inputs

Key responsibilities

Adherence to company and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.
Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
Coordinate with key stakeholders (local regulatory authority and local MC etc.) to achieve rapid/ high quality submissions and approvals
Actively communicate with CDE reviewers for technical discussion and Panel Meeting
Maintain product licenses through timely renewal to high standard
Monitor and promptly report status of all product licenses
Implement submission plan for products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on time
Maintain complete documentation records.
Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders
Maintain and update local and global regulatory support and information systems
Communicate changes to regulatory status to all stakeholders
Provide appropriate support to other functions
Under supervision: establish relationship with local regulatory authorities.
Build up good image through high professional standard of application, response to enquiries etc.
Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings
Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory influence through company initiatives and/or industry association joint forces.
Maintain up-to-date knowledge of local regulatory environment
Communicate changes of local regulatory environment

Required experience and qualifications

1. Bachelor or above in Pharmacy, Medical, Biology or related field
2. Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.
3. Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.
4. Project management primary level skill
5. Chinese and English (proficiency level)
6. Computer skill: word, excel, power point , adobe acrobat

Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.