Regulatory and Quality Expert - Animal Health

Possesses extensive experience in CMC international Regulatory Affairs and Quality Assurance, with a deep understanding of EMA guidelines and submission requirements (Leadership and hands-on operational)

Expert in developing, implementing, and managing Quality Management Systems, with +20 years of experience in the Animal Health industry

Skilled in pharmaceutical product lifecycle management, from development to marketing application, with a focus on CMC Regulatory Affairs and Quality Assurance

Proficient in scientific writing, dossier preparation, and regulatory compliance, with a strong background in analytical method development and validation

Overall responsibility for managing and executing product development (laboratory, pilot plant, and manufacturing scale-up) for veterinary pharmaceutical products

Manage the pharmaceutical development team while collaborating in a multidisciplinary team to define the formulation and manufacturing processes within the constraints of clinical, legal, analytical, regulatory and production requirements

Define the scopes and timelines for projects, ensure projects milestones are delivered and all operations and functions are in compliance with company procedures, scientific and cGMP regulatory guidelines and product development decisions and strategies

Author CMC regulatory documents

Write and review of technical documents

Dossier preparation, filing, maintenance, variations, as well as reviewing dossiers

Review and preparation of Active Substance Masters Files (ASMF)

Scientific writing services and preparation of CMC documents and regulatory CMC compliance advice

Build and maintain strong working relationships with clients, suppliers, contract research and contract manufacturing organisations

Ensuring that activities are managed collaboratively, efficiently, and effectively throughout product development life cycle (Be on-site, as necessary)

Direct active substance physicochemical and solid-state property characterisation including crystallinity assessment, solubility determination, and stability evaluation

Design and direct formulation development studies to develop clinical and commercial formulations

Oversee analytical method development, validation, active substance and medicinal product testing and stability

Development of active substance and medicinal product specifications, including qualification of impurities

Management of Quality Management System and ensuring appropriate primary packaging

Development and validation of microbiological methods (bacterial identification, bioburden, endotoxins, sterility, microbiological assay)

Registered as Qualified Person since September 2020

Compile and submit, CMC regulatory documents according to regulatory requirements within the EMEA (Europe, Middle East and Africa) and respond to regulatory authorities’ questions with strict deadlines

Maintain and update existing regulatory authorisations and regulatory files

Lead or represent Regulatory Affairs in project teams

Responsible for complaint handling

Prepare, review, and approve SOPs and write pharmaceutical expert reports

Manage regulatory activities relating to specific portfolio of products/projects (product owner)

Compilation Drug Master Files (DMFs)

Responsible for organizing and controlling all aspects of pharmaceutical product development including: development and validation of analytical methods, process validation studies, calibration and maintenance of secondary reference standards

Impurity profiling active substances

Stability testing on active substances and finished products according to ICH/VICH guidelines, as well as photo-stability testing, in-use stability testing, freeze-thaw cycle stability testing

Experience with the following analytical techniques: UPLC; HPLC; GC, MS, TLC, Raman, NIR, IR and UV-VIS spectroscopy; In-vitro dissolution testing; Particle size distribution by laser diffraction; Optical rotation; Titration assay; classical pharmacopoeial tests; and microbiological tests under GMP rules and ICH guidelines