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Diana Grelus

@dianagrelus

Regulatory Affairs Manager at B. Braun Shared Service, coordinating regulatory submissions and market access across Near Middle East and Africa countries.

Romania

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What I'm looking for

I'm eager to expand my horizons and contribute to innovative projects, fostering collaborative relationships and successful outcomes in diverse teams.

At B. Braun Shared Service, I coordinate regulatory activities for Near Middle East and Africa countries, working with local teams and serving as their liaison with Global Regulatory Affairs.

I prepare and submit product registrations, withdrawals, and variations to regulatory authorities, and monitor regulatory changes for their impact on products.

I also share regulatory updates with the team and support internal and external audits and inspections to help ensure adherence to regulatory standards.

Previously, I worked as an HPLC Analyst at STADA Hemofarm, conducting analysis of finished products and active pharmaceutical ingredients. I also gained pharmacy experience at Farmina Pharmacy, including stock management and pharmaceutical organization.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs Manager - Arabic Countries Coordinator

Current

B. Braun Shared Service

Aug 2019 - Present (7 years 2 months)

Coordinate regulatory activities for Near Middle East and Africa countries, serving as liaison between local teams and Global Regulatory Affairs. Prepare and submit regulatory documents, monitor regulation changes, and support audits and inspections.

Regulatory Affairs Product Registrations Regulatory Compliance Audit Inspections Project Management Stakeholder Management

HPLC Analyst

STADA Hemofarm

Mar 2016 - Aug 2019 (3 years 5 months)

Conducted HPLC analysis on finished products and active pharmaceutical ingredients, focusing on dosage, impurities, and dissolution testing. Managed receipt, tracking, and dispensing of controlled substances and collaborated with authorities for proper disposal.

HPLC Pharmaceutical Analysis Data Interpretation Quality Control Regulatory Compliance

Intern

Farmina Pharmacy

Jul 2013 - Jun 2016 (2 years 11 months)

Gained experience in a pharmacy specialized in drug preparation, including stock management, invoice processing, and organization and classification of pharmaceuticals. Developed skills in inventory tracking and quality assurance checks.

Pharmacy Operations Stock Management inventory tracking Quality Assurance

Education

Degrees, certifications, and relevant coursework

West University of Timișoara

Master of Science, Clinical Chemistry and Laboratory

2016 - 2018

Master of Science in Clinical Chemistry and Laboratory from West University of Timișoara from 2016 to 2018.

University of Medicine and Pharmacy 'Victor Babeș' Timișoara

Master of Pharmacy, Pharmacy

2010 - 2015

Master of Pharmacy (MPharm) from the Faculty of Pharmacy. Final thesis on rheological characterization of gels based on copolymers of methylvinyl ether with maleic anhydride.