Regulatory Affairs Specialist (Submission Excellence Specialist)

Responsibilities

Preparation and elaboration of “ready to submit/use” dossier for new registration, tenders, site registration/renewals, post approval changes (administrative, CMC, labeling, etc.) and renewals in order to comply with region strategic plan and the maintenance of the marketing authorizations for the products already in the market for the countries of responsibility.

Dispatch “ready to submit/use” dossiers to affiliate/distributor according to business priorities.

Leadership

• Develop and maintain excellent relationships and communication with GRA platforms and affiliates/distributors to ensure operational excellence and optimal stakeholder management/support

• To be aware of new regulation changes via collaboration with affiliates/distributors for impact assessment including aligned follow up action to be assured of operational excellence

• Optimization in ways of working, ensuring continuous improvement of regulatory tools

 Dossier Elaboration for Regulatory Submissions

• To undertake all necessary dossier elaboration, evaluation and timely dispatch for regulatory submission in accordance to local regulations with agreed business priorities to ensure compliance of all assigned products in the countries responsible

• To assist with the development of optimal regulatory strategies in collaboration with key internal stakeholders to drive  submission and approvals in accordance with agreed business priorities

• Keep up-to-date with developments in regulatory affairs and assist with implementation of any required revisions to systems and processes

• Ensure the quality of final dossiers sent, after considering TRT (thoughtful risk taking) approach with full alignment with the country

• Manage the response of deficiency letters from HAs of the countries in charge (review information, coordinate time of response) according to the requirements of the affiliates and regulatory authorities on time

• Ensure the delivery of the dossier to the affiliate, with risk assessment (and TRT), if applicable, and in full alignment with business priorities

 Manage and track activities

• Keep track of planned dispatches/renewals and variations, provide support for deviations

• Provide accurate and timely information to ensure regulatory database is updated (as applicable)

• Ensure timely dispatch, tracking and archiving of dossier to the countries responsible and timely update of global database/repository where applicable

Requirement

• Bachelor's degree of Pharmacy.

• Minimum of 2 years’ experience from the pharmaceutical or healthcare sector

• Experience in regulatory affairs, excellent writing and presentation skills

• Strong knowledge of regulatory requirements for variations, renewal and labeling of countries under his/her responsibility

• Good command of spoken and written English

• Time management, Proactive, Able to work in team and individually

Work Schedule: Mon - Fri, 8.00 - 17.00 (Flexible)

Company: International Pharmaceutical Company

Location: MRT Samyan

This is a contract position with Manpower for 1 year (contract renewal base on company consideration)

If you are interested, please click apply with your resume (with photo) attached and provide your expected salary. All information provided will be kept confidential and used only for recruitment process.