Director Regulatory Affairs – Cannabinoids
Basel, Switzerland | Full-Time
Contract Type: Permanent
Closing date:
Reference: VN1697
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Who we are
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines and consumer wellness products.
About the role:
As Director Regulatory Affairs – Cannabinoid Strategy, you will be accountable for the global regulatory strategy for cannabinoid products.
Cannabinoids have shown promise in healthcare, but there is a huge need for science-backed products and standards. Our ambition is to be a world leader in developing safe and effective cannabinoid products to meet significant unmet medical needs – The successful candidate will be passionate about delivering on this ambition.
Core responsibilities:
• Active engagement in the Cannabinoid Leadership team and act as liaison between the category and global regulatory leads (GRLs) that sit on respective project teams
• Together with respective GRLs collaborate and influence to ensure innovative, proactive and risk balanced regulatory strategies are established and properly addressed in development plans
• Work with external affairs and regulatory policy teams to monitor, anticipate and facilitate changes in the regulatory environment and effectively translate these into the regulatory strategies with the respective GRLs
• Provide regulatory advice and participate in due diligence activities in support of M&A or licensing activities
Qualifications/Experience:
• Advanced scientific degree
• Significant experience in regulatory affairs
• Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
• Demonstrated ability to break down complex, scientific issues and communicate regulatory implications
• Proven success in negotiating regulatory objectives with health authorities
• Strong knowledge of FDA, EMA and other international and national regulations applicable to cannabinoid / medical cannabis products
• Experience with due diligence activities
• Comfortable working in a fast-paced, launch-oriented environment
Our ambition in cannabinoids
At Vectura Fertin Pharma, we are passionate about finding new and better ways to enhance life.
We believe that cannabinoids have a role to play in healthcare and wellness. But today there is a huge need for science-backed products and standards for safety, dose, and quality.
Our ambition is to be a leader in developing and commercializing safe, scientifically tested, and best-in-class medical and wellness cannabinoid products that patients and consumers can trust.
We have the scientific rigor, patient and consumer insights and the right capabilities to responsibly lead the way, with a unique combination of innovative technologies in inhalation and oral delivery systems and prescription drug development expertise.
We have a clear mission to unlock the potential of cannabinoids to address unmet medical and health needs while meeting the potential requirements of a complex legal and regulatory environment.
This is a unique opportunity to be part of a team whose pioneering approach is rooted in robust science and clinical research programs.
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines and consumer wellness products.
About the role:
As Director Regulatory Affairs – Cannabinoid Strategy, you will be accountable for the global regulatory strategy for cannabinoid products.
Cannabinoids have shown promise in healthcare, but there is a huge need for science-backed products and standards. Our ambition is to be a world leader in developing safe and effective cannabinoid products to meet significant unmet medical needs – The successful candidate will be passionate about delivering on this ambition.
Core responsibilities:
• Active engagement in the Cannabinoid Leadership team and act as liaison between the category and global regulatory leads (GRLs) that sit on respective project teams
• Together with respective GRLs collaborate and influence to ensure innovative, proactive and risk balanced regulatory strategies are established and properly addressed in development plans
• Work with external affairs and regulatory policy teams to monitor, anticipate and facilitate changes in the regulatory environment and effectively translate these into the regulatory strategies with the respective GRLs
• Provide regulatory advice and participate in due diligence activities in support of M&A or licensing activities
Qualifications/Experience:
• Advanced scientific degree
• Significant experience in regulatory affairs
• Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
• Demonstrated ability to break down complex, scientific issues and communicate regulatory implications
• Proven success in negotiating regulatory objectives with health authorities
• Strong knowledge of FDA, EMA and other international and national regulations applicable to cannabinoid / medical cannabis products
• Experience with due diligence activities
• Comfortable working in a fast-paced, launch-oriented environment
Our ambition in cannabinoids
At Vectura Fertin Pharma, we are passionate about finding new and better ways to enhance life.
We believe that cannabinoids have a role to play in healthcare and wellness. But today there is a huge need for science-backed products and standards for safety, dose, and quality.
Our ambition is to be a leader in developing and commercializing safe, scientifically tested, and best-in-class medical and wellness cannabinoid products that patients and consumers can trust.
We have the scientific rigor, patient and consumer insights and the right capabilities to responsibly lead the way, with a unique combination of innovative technologies in inhalation and oral delivery systems and prescription drug development expertise.
We have a clear mission to unlock the potential of cannabinoids to address unmet medical and health needs while meeting the potential requirements of a complex legal and regulatory environment.
This is a unique opportunity to be part of a team whose pioneering approach is rooted in robust science and clinical research programs.
Basel, Switzerland
Messeplatz 10
CH-4058
Basel
Switzerland