Denise Jackman

Blackmores is a leading complementary medicine company supplying health supplements and complementary medicines under the following brands: Blackmores, BioCeuticals, and Pure Animal Wellbeing.

Directed regulatory teams for multiple brands across domestic and international markets, with a team of 22 reports working across Australia, and 7 in established international markets in Asia.

• Oversaw regulatory operations in 13 markets to maintain compliance with regulations, policies and requirements.
• Participated in strategy-focused discussions with departmental leadership to assess project milestones.
• Developed policies and procedures to ensure compliance with internal standards.
• Oversaw strategic product registration planning and implementation to ensure organizational goals were met.
• Managed annual budgeting and licensing costs, including savings.
• Collaborated with senior leadership to set long-term objectives for the company.
• Coordinated resources across regulatory departments to maximize productivity levels.
• Monitored industry trends to identify regulation change impacts, and opportunities for expansion and innovation.
• Maintaining the current database of knowledge of relevant regulatory environments across local and export markets, and updating relevant stakeholders.
• Contributing to significant TGA and market regulator reform consultation on behalf of the Blackmores Group. Taking a proactive approach to identifying and acting on insights or issues affecting the regulatory environment, and driving regulatory change.
• Structure and build a highly skilled regulatory team, creating efficiencies and consistency within the team.
• Engaged proactively with industry associations to stay updated on regulatory shifts, and adapt to evolving regulations.

• Oversaw Blackmores ANZ regulatory team with 11 direct reports.
• Keeping all updates regarding the ANZ regulatory landscape communicated to relevant parties.
• Represented Blackmores Group in the TGA reform consultation.
• Managed regulatory compliance reviews and promotional material disputes.
• Ensured accuracy and completeness in preparing regulatory submission papers.
• Approved promotional and educational content to ensure compliance with regulations.
• Navigated Complementary Medicines Australia (CMA) and Australian Self Medication Industry Association (ASMI) to gain ad approvals.
• Guided business on compliance with Therapeutic Goods Advertising Code and TGA standards for complementary medicines.
• Coordinated with product development, marketing, education, external consultants, manufacturers, and regulatory authorities to ensure timely delivery of products.
• Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
• Investigated noncompliance issues, and suggested appropriate risk-based actions.
• Reviewed and prepared risk evaluations to manage corporate risks and regulatory compliance.

• Merck Serono is a biotechnology leader with products in the treatment of cancer, neurodegenerative diseases, infertility, endocrine and metabolic disorders, cardiovascular disease, and other areas of unmet medical needs.
• Prepared and submitted category 3 applications, line extensions, and product maintenance applications to the TGA and Medsafe.
• Critically appraised dossier packages to identify and resolve any deficiencies prior to submission.
• Managed and successfully resolved requests for information with TGA and Medsafe.
• Assessed promotional materials for compliance with the Medicines Australia Code of Conduct.

• Genzyme is a leader in advanced technologies in the life sciences, with products and services focused on rare inherited disorders, kidney disease, orthopedics, transplant, cancer, and diagnostic testing.
• Maintained regulatory compliance of registered medicines and medical devices in Australia and New Zealand, via variations, self-assessable notifications, and safety-related notifications with the TGA and Medsafe.
• Prepared and reviewed product labels, Product Information, and Consumer Medicine Information documents in accordance with the registered information, local legal, and regulatory requirements, and communicated changes to regulatory agencies as required.
• Detailed internal evaluation of documentation prior to submission to ensure that any deficiencies or complex issues are addressed in anticipation of regulator questions.
• Maintained GMP clearances, and applied for new GMP pre-clearances with the TGA.