Associate Director, Regulatory Affairs - Nicotine Replacement Therapies
Copenhagen, Denmark | Full-Time
Contract Type: Permanent
Closing date:
Reference: VN1710
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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, nicotine replacement therapies (NRT), and consumer wellness products.
As Senior Manager / Associate Director – Global Regulatory Lead (GRL), you will be accountable for the regulatory strategy for assigned product(s).
Core responsibilities:
• Develop and execute a global regulatory strategy for assigned products (primarily OTC)
• Represent regulatory on inhouse product teams and/or category leadership teams, as applicable and drive regulatory discussion topics
• Develop registration strategies and plans aimed at achieving regulatory approval, optimize product labeling or ensure compliance
• Lead registration activities assigned products (geographic extension)
• Support development of and lead review of core promotional / non-promotional materials from regulatory perspective
• Provide regulatory expertise to new product developments (primarily generics, hybrid)
• Lead correspondence with regulators, meeting requests, inhouse preparation and regulatory interactions, where relevant
• Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to the product/projects, submission targets and proactively communicates them to implement necessary adjustments to strategies or content
• Support as appropriate, internal and external audits and regulatory inspections for relevant product scope
• Selection and management of vendors (outsourced activities)
Role Requirements:
• Relevant scientific degree
• Significant experience in regulatory affairs (+ 7 years)
• Well versed in communicating regulatory strategy, issues, and risks in written and verbal format
• Significant experience from regulatory review of promotional and non-promotional materials
• Strong knowledge of European regulations applicable to drug development, registrations and maintenance of marketing authorizations (additionally Canada and APAC an advantage, other relevant experience considered)
• Experience in leading preparation for meetings and communications with regulators, specifically in the EU, UK or Canada (other relevant experience considered)
• Experience from generics or hybrid developments an advantage
• Experience from OTC an advantage
• Experience working in matrix teams
• Comfortable working in a fast-paced, launch-oriented environment
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.
Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
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, nicotine replacement therapies (NRT), and consumer wellness products.
As Senior Manager / Associate Director – Global Regulatory Lead (GRL), you will be accountable for the regulatory strategy for assigned product(s).
Core responsibilities:
• Develop and execute a global regulatory strategy for assigned products (primarily OTC)
• Represent regulatory on inhouse product teams and/or category leadership teams, as applicable and drive regulatory discussion topics
• Develop registration strategies and plans aimed at achieving regulatory approval, optimize product labeling or ensure compliance
• Lead registration activities assigned products (geographic extension)
• Support development of and lead review of core promotional / non-promotional materials from regulatory perspective
• Provide regulatory expertise to new product developments (primarily generics, hybrid)
• Lead correspondence with regulators, meeting requests, inhouse preparation and regulatory interactions, where relevant
• Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to the product/projects, submission targets and proactively communicates them to implement necessary adjustments to strategies or content
• Support as appropriate, internal and external audits and regulatory inspections for relevant product scope
• Selection and management of vendors (outsourced activities)
Role Requirements:
• Relevant scientific degree
• Significant experience in regulatory affairs (+ 7 years)
• Well versed in communicating regulatory strategy, issues, and risks in written and verbal format
• Significant experience from regulatory review of promotional and non-promotional materials
• Strong knowledge of European regulations applicable to drug development, registrations and maintenance of marketing authorizations (additionally Canada and APAC an advantage, other relevant experience considered)
• Experience in leading preparation for meetings and communications with regulators, specifically in the EU, UK or Canada (other relevant experience considered)
• Experience from generics or hybrid developments an advantage
• Experience from OTC an advantage
• Experience working in matrix teams
• Comfortable working in a fast-paced, launch-oriented environment
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.
Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
Copenhagen, Denmark
Langebrogade 5
1411 Copenhagen
Denmark