Job Description

: Position is 50% Onsite

Title: Global Regulatory Affairs manager

Position Responsibilities:
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 Client 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.

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.

Represent GRS and/or GRS International on specific non-product related projects when input is required or when an opportunity arises.

Interface between Global and Local, the GRM lead International Regulatory Teams engage the local GRS regulatory teams, communicate Project specific information (follow-up, update) to local teams, ensure alignment between registration/submission requirements and development plans, translate global regulatory expectations into local plans and lead the execution of these plans, digest and communicate Global Regulatory plans, including HA engagement plans to countries, digest and communicate results for key clinical trials, obtain aligned regulatory position, Represent and deliver the Global TA position, track the execution of the global submission plan.

Degree Requirements:
Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).

Experience Requirements
2-4 years of relevant experience expected , especially in Intercontinental region

Demonstrated ability to break down complex, scientific content into logical components.

Demonstrated ability to facilitate issue resolution.

Demonstrated ability to organize / prioritize tasks.

Understanding of tactical role of GRS in the drug development process.

Understanding of general global regulatory requirements for drugs in development.

Understanding of PD&C process and specific GRS responsibilities / deliverables at PD&C Decision Points for International

LanceSoft