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Regulatory Affairs Manager
Wilrijk
Summary
With extensive experience as a Regulatory Affairs Manager and Senior Research Scientist in the pharmaceutical industry, I bring a strong foundation in conducting pre-clinical and clinical trials, managing pharmaceutical and biological projects, and ensuring seamless regulatory submissions and compliance. My expertise has directly contributed to successful product approvals, supported by my ability to navigate complex regulatory environments and develop effective strategies.
I excel in collaborating with cross-functional teams and staying abreast of the latest regulatory developments. Additionally, my background includes significant experience in distribution quality (GDP) from a previous quality role, further broadening my skill set. My post-master's studies in laboratory animal science, ongoing education in regulatory dossiers, participation in ethical committees, and hands-on experience in distribution quality are assets I leverage to deliver results.
Overview
18
18
years of professional experience
5
5
Languages
Work History
Regulatory Affairs Manager
Huvepharma
05.2022 - Current
- Part of the vaccines regulatory team and involved in pre-and post approval regulatory activities.
- Collaborating with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Representing the company during communications with global regulatory agencies.
- Managing pre-clinical GCP and GLP studies conducted by CROs (protocol design, report review).
- Writing and compiling regulatory dossiers for EMA (centralized procedures, decentralized procedures) and dossiers for the international markets.
- Analyzing field studies and reports, compiled information and submitted concise and informative summaries.
- Evaluating emerging legislation and its potential impact on current products or future developments.
- Optimizing submission procedures to enhance efficiency and secure timely regulatory approvals.
- Developing strong relationships with key stakeholders, facilitating open communication channels between organizations.
- Coordinating with clinical teams to ensure compliance with regulatory requirements during pre-and post-market phases of product development.
- Actively participated in industry conferences and workshops, enhancing professional networks while staying up-to-date on best practices in regulatory affairs management.
Sr Research Scientist - Global Vaccines Clinical Development
Elanco Animal Health
03.2019 - 04.2022
- Contributed as a clinical SME to and/or lead project teams with strong strategic focus, quality awareness and scientific and technical expertise with the ultimate goal of getting products approved.
- Ensured implementation of decisions and strategies agreed with line management.
- Acted as project manager to proactively develop and communicate project clinical strategy, budgets, phase transitions, etc...
- Represented the project team at scientific review and portfolio management boards.
- Planned, coordinated, conducted and/or supervised clinical activities (safety and efficacy) required for registration/licensing of new products, product line extensions and/or product remediation, involving international teams.
- Study Director for pre-clinical safety studies in accordance with GLP.
- Sponsor Representative/Person Responsible, Study Investigator or Study Personnel for animal studies, including studies in accordance with GCP.
- Reported and presented scientific/technical results internally and/or externally through publications, patents and/or presentations at scientific congresses or conferences.
- Wrote or supported the generation of registration documents.
- Transferred knowledge and information from R&D to regulatory affairs, quality, commercial and other areas of R&D.
- Accountable that all project documentation was complete, accurate and appropriately retained to ensure product development remains transparent and reproducible.
QA Manager Benelux and Nordics
Elanco Animal Health
05.2017 - 02.2019
- Led the affiliate management to ensure that all operations of the affiliate comply to applicable GxP, other applicable company quality standards and local regulations.
- Effectively partnered with affiliate leaders to ensure proactive identification and resolution of issues.
- Demonstrated continuous improvement and minimized risk by a routine self assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.
- Accountable for product quality related matters, escalated any local product quality related issue to regional quality leadership and affiliate management and led / collaborated in any local action to be taken as a result of that (i.e. recall, counterfeit etc...).
- Accountable for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, procedure reviewer and approver and maintenance of the Quality Plan.
- Ensured that distribution, product release and warehousing was compliant with Elanco standards and external regulatory requirements (i.e products returned/reintegration, products recall).
- Ensured that Quality agreements, including self-inspection & audits, were in place covering affiliate processes and GMP service providers.
- Monitored, trended, interpreted & reported on Quality metrics & lead continuous improvement activities, in areas including, but not limited to, quality events, complaints and approvals.
- Developed local talent to sustain competitiveness; this includes coaching employees; developing and implementing impactful training plans; managing & evaluating performance against expectations.
- Active member of the Elanco Ethical Review Board / Elanco IACUC
- Supervisor of the Quality Associate located in Denmark
Sr. Research Scientist Companion Animal Vaccine Development
Elanco Animal Health (a division of Eli Lilly)
04.2014 - 04.2017
- Study monitor for vaccine target animal safety trials (GLP), onset and duration of immunity trials and efficacy field trials (GCP) in US and EU for companion animals and swine
- Wrote GLP and GCP protocols and reports
- Selected and contacted CRO's for collaboration
- Negotiated contracts with CRO's
Research Scientist Companion Animal Product Development
Elanco Animal Health (a division of Eli Lilly)
07.2011 - 03.2014
- Study monitor for target animal safety trials (GLP) and field trials (GCP) in US and EU
- Wrote GLP, GCP protocols and reports and SOPs
- Selected and contacted CRO's for collaboration
- Negotiated contracts with CRO's
- Managed study budgets
- Project leader of several projects
- Member of different project teams
- Support to the regulatory department and compiling scientific files for FDA and EMA
- Elanco person of contact for the cat colony at University of Gent
- Member of the Elanco Ethical Review Board
- Writing scientific publications for peer-review journals
Research Scientist Companion Animal Product Development
Janssen Animal Health (Johnson and Johnson)
09.2006 - 06.2011
- Study director for in-house non-GLP studies (companion animals)
- Study monitor for target animal safety trials (GLP) and field trials (GCP) in US and EU
- Wrote GLP and GCP protocols and reports
- Performed marketing trials
- Selected and contacted CRO's for collaboration
- Negotiated contracts with CRO's
- Managed study budgets
- Project leader
- Member of different project teams
- Support to the regulatory department and compiling scientific files for FDA and EMA
- Active support during FDA audits (front room and back room)
- Writing of SOPs
- Responsible for the Janssen Animal Health dog and cat colony
- Writing of scientific publications for peer-review journals
Education
Ph.D. - Veterinary Bacteriology And Pathology
University of Ghent
Ghent, Belgium07-2006
Master of Science - Laboratory Animal Science
University of Ghent
Ghent, Belgium07-2006
Veterinarian -
University of Ghent
Ghent, Belgium06-2002
Skills
Regulatory strategy
Regulatory submissions
Regulatory agency applications
Clinical trial oversight
GxP knowledge
Technical writing
Project management
Quality assurance
Clinical development
Health authority negotiations
EMA interactions
Teamwork and collaboration
Awards
- 1999: Ambroise Jaques Mathieu und Marie Eugène Mathieu Stiftung' donation.
- 1999: Best Student Veterinary Medicine (bachelor degree, University of Antwerp).
- 2002: Tom & Co award best thesis companion animals (University of Ghent).
- 2004: Best oral presentation on the 6th International Workshop on Pathogenesis and Host Response in Helicobacter Infections, Denmark.
- 2009: J&J Encore Award
- 2010: J&J Encore Award
- 2011: J&J Global Standards of Leadership Award
Software
MS Excel
Adobe photoshop
Adobe Indesign
Adobe Illustrator
Interests
Travel
Tennis
Snowboarding
Timeline
Regulatory Affairs Manager
Huvepharma
05.2022 - Current
Sr Research Scientist - Global Vaccines Clinical Development
Elanco Animal Health
03.2019 - 04.2022
QA Manager Benelux and Nordics
Elanco Animal Health
05.2017 - 02.2019
Sr. Research Scientist Companion Animal Vaccine Development
Elanco Animal Health (a division of Eli Lilly)
04.2014 - 04.2017
Research Scientist Companion Animal Product Development
Elanco Animal Health (a division of Eli Lilly)
07.2011 - 03.2014
Research Scientist Companion Animal Product Development
Janssen Animal Health (Johnson and Johnson)
09.2006 - 06.2011
Ph.D. - Veterinary Bacteriology And Pathology
University of Ghent
Master of Science - Laboratory Animal Science
University of Ghent
Veterinarian -
University of Ghent
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