Translate:
Regulatory Affairs Consulting at RegulatoryEdge
Why RegulatoryEdge
Enisa Savic Hjelmaas
Why RegulatoryEdge
Our Principal has unique experience across all four of these key areas: regulatory affairs, new business development, pharmacovigilance and medical information. Most pharmaceutical consultants specialise in just one of these areas, which sets me apart.
Our past and current clients are local and overseas pharmaceutical companies who are wel
Our Principal has unique experience across all four of these key areas: regulatory affairs, new business development, pharmacovigilance and medical information. Most pharmaceutical consultants specialise in just one of these areas, which sets me apart.
Our past and current clients are local and overseas pharmaceutical companies who are well established in Australia and looking to grow their business further, or are looking to establish their Australian affiliate. Their portfolio ranges from ethical medicines including Biological, Gene Therapies to Over the Counter Medicines, Medical Devices and Cosmetics
Our Strengths
Enisa Savic Hjelmaas
Why RegulatoryEdge
● Superlative knowledge – Enisa understands regulatory requirements, and work to keep abreast of amendments and updates to policy and procedures
● Exemplary leadership – Enisa employs strong leadership skills to set pathways, report progress and co-ordinate teams
● Consummate communication – Enisa conveys complex scientific research and d
● Superlative knowledge – Enisa understands regulatory requirements, and work to keep abreast of amendments and updates to policy and procedures
● Exemplary leadership – Enisa employs strong leadership skills to set pathways, report progress and co-ordinate teams
● Consummate communication – Enisa conveys complex scientific research and data and relay regulatory requirements with ease and in different languages
● Ultimate resilience – Regulatory compliance is rarely straightforward or quick to achieve and requires mental stamina and the ability to constantly refresh and renew an approach
Enisa Savic Hjelmaas
Enisa Savic Hjelmaas
Enisa Savic Hjelmaas
Our Principal - Consultant Enisa Savic Hjelmaas is commercially orientated pharmacologist with extensive experience in Scientific Affairs working across a number of various functions, product portfolios and therapeutic areas within the pharmaceutical industry. She is multilingual with international experience.
Key area of expertise includ
Our Principal - Consultant Enisa Savic Hjelmaas is commercially orientated pharmacologist with extensive experience in Scientific Affairs working across a number of various functions, product portfolios and therapeutic areas within the pharmaceutical industry. She is multilingual with international experience.
Key area of expertise include regulatory affairs consulting in area of regulatory development, submissions and commercialisation of products, critical review and analysis of manufacturing, toxicology and clinical data, and negotiation of win-win outcomes with regulatory authorities. Other expertise include medical affairs and pharmacovigilance as well as skills such as project management, and leadership of cross functional initiatives with global scope to ultimately achieve greater business efficiencies and maximise commercial opportunities.
On personal level Enisa is creative, strategic, efficient, and results oriented problem solver with solid sense of business, persuasive negotiation skills who enjoys challenging environments and being a key member of achievement oriented team.
Professional and Industry Memberships
Proudly Supporting Australian Industry
Dear Valued Clients and Partners,
RegulatoryEdge is evolving into HILAXON Pty. Ltd. Click to learn more about our journey and what this means for you.