Sorin Alb B. Eng.
Sen Mgr Regulatory Affairs @Ppd
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WORK HISTORY
Sen Mgr Regulatory Affairs @Ppd
Mississauga, ON, CA
EDUCATION
Universitatea „Babeș-Bolyai” din Cluj-Napoca
Diploma
Seneca Polytechnic
Certificate
SKILLS
ABOUT SORIN ALB B. ENG.
Supporting customers with Regulatory Intelligence research, planning, and dossier filing for bringing new products (pharmaceuticals, medical devices, natural health products and cosmetics) into Canada. Solid and liquid generic and brand name pharmaceuticals regulatory affairs experience for new products as well as product life-cycle management in Canada, USA, E.U, and other less regulated markets. Working experience in filing the following submissions: ANDA, CBE0, CBE30, Amendments, Supplements, NDS, ANDS, S/ANDS, NC, Clarifax responses, Product Monograph updates, CTAs, MDs class II applications and renewals, and others. Managing customers\' teams to ensure the data conforms to the market requirements, is finalized and submitted on time to meet the business\' targets and objectives. Specialties: Ensure that documentation complies with regulations, is complete and suitable for submission. Initiate, review and approve artwork (labels, IFUs, etc.) Participate in working groups within the department and the company. Interact with regulatory colleagues, extra-departmental personnel, as appropriate to ensure that the projects are completed to the agreed timelines. Respond to questions from regulatory agencies Maintain up-to-date knowledge on regulations/guidelines related to projects/products.
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