Regulatory Assistant Manager
A Japanese global pharmaceutical company are looking for a Regulatory Assistant Manager.
Duties and Responsibilities:
1. Improve the regulatory management system with Regulatory Manager
- Develop and implement a Regulatory Program including policies, procedures (SOPs), insuring that all governmental regulatory regulations including MHRA requirements for the company products are achieved.
- Prepare, record, and manage documents necessary to establish the system of Regulatory Affairs in order that the compamy will have been selling regulatory products sustainably. SOPs of which include;
l The rules to record all information related with Regulatory Affairs
l The rules to maintain our certifications
l The guidelines to address new product developments
2. Accelerate product developments and keep certifications the latest
- Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes. Especially for;
l High Class Medical devices like Class IIb and III
l Medicinal products
l M&A business from regulatory points of view
l Batch testing of our devices implemented by our own facilities
- In-charge with the timely approval and renewal of product licenses, company certificates, through working with Regulatory officials, Notified div(s) and regulatory consultant(s).
- Deal with audits which are implemented by Notified div(s) and consumers, which includes supporting our own factory(s) when audited in order to maintain our certificates.
- Review technical dossier of products and prepare additional documents where necessary.
- Handle post-marketing activities and yearly reporting requirements of company and product licences.
3. Analyse relevant regulatory trends
- Keep updated with regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
- Maintain a current awareness of the regulatory requirements for the general legislation and guidelines (for instance REACH and Environmental regulations including recycling etc...) in EU.
1. Bachelor’s Degree preferred
2. Experiences in Regulatory Affairs or Certifications as Auditor of Notified div(s) for CE certificated products
3. In depth knowledge of relevant regulatory requirements
4. MDR transition’s experiences desirable
5. Strong computer skills including Microsoft Office and Databases.
6. Communication skills-verbal and written of Chinese or Japanese
7. Must be able to travel
Mon – Friday 08:30 – 17:30
Eligible to work in the UK without any restriction
About our client
Japanese global pharmaceutical company