- Expiry Date: 20 August 2021
Responsible for driving regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of Bclient MS products.
Responsible for interactions with Country Regulatory managers/regional leads regarding product registrations.
Drives and support local projects and department related assignments.
Responsible to keep up to date with the regulatory environment within the industry.
Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases and manage all updates in our RIM Veeva vault system
Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Logistics function.
Responsible for overall regulatory related topics for assigned products /therapeutic area.
Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
Manage, track, review regulatory deliverables from external partners in line with vendor manager
Doctor of Pharmacy or equivalent
2-4 years of relevant experience expected , especially in Intercontinental region
Demonstrated ability to break down complex, scientific content into logical components.
Ability to write in a clear, concise, and persuasive manner
Strong project management skills
Highly proficient in the use of Microsoft WORD and POWERPOINT
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.