Ipsen
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Head of US Regulatory Affairs & Quality
role at
Ipsen
Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered. 3 days ago Be among the first 25 applicants
The Head of Regulatory Affairs and Quality for US affiliate oversees all commercial regulatory affairs activities and quality oversight for the entire Ipsen portfolio marketed in US.
This position is responsible for providing guidance on regulatory affairs activities for Ipsen products under development in US, in collaboration with the head of Global Regulatory Affairs US lead and global therapeutics area leads. The role ensures GxP compliance across US affiliates and that resources and processes meet US regulations.
The Head of US Regulatory Affairs & Quality will serve as a principal regulatory liaison to the FDA for all US affiliate activities during the product lifecycle.
Main Responsibilities / Job Expectations The Head leads a team of 10 to 15, with 2 main direct reports covering regulatory affairs and quality activities.
US Regulatory Affairs Activities
Manage all regulatory commercial activities for marketed products in the US.
Ensure resources and processes support product lifecycle management.
Lead development of compliant sales training, advertising, and literature.
Advise Medical Liaison and Communications teams on regulatory issues.
Oversee regulatory review and approval of promotional materials.
Assess and recommend actions to mitigate regulatory risks.
Manage US regulatory vendors and budget.
US Quality Activities
Oversee GxP activities for marketed and developmental products.
Ensure resources and processes support compliance with US regulations.
Represent US quality within the Ipsen global network.
Harmonize GxP processes between global and affiliate teams.
Regulatory Submission & Stakeholder Management
Collaborate on FDA interactions (INDs, NDAs, MAAs, etc.).
Review clinical and manufacturing documentation relevant to Ipsen products.
Support business development activities, including due diligence and partner interactions.
Work closely with Global Regulatory Affairs to align US market insights.
Ethics & Compliance
Maintain compliance with reporting requirements and laws.
Ensure adequate structures and controls are in place.
Adhere to Ipsen’s ethical standards and SOPs.
Knowledge, Abilities & Experience Education / Certifications:
Degree in life sciences; advanced degrees (PhD, PharmD, MD, MSc) preferred with regulatory and GxP experience.
Experience:
8-10 years in biopharma regulatory affairs or related fields.
Leadership experience in regulatory affairs.
Deep knowledge of US regulations and FDA experience.
Preferred experience in oncology, neurology, or rare diseases.
Languages:
Fluent in English; French is a plus.
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Head of US Regulatory Affairs & Quality
role at
Ipsen
Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered. 3 days ago Be among the first 25 applicants
The Head of Regulatory Affairs and Quality for US affiliate oversees all commercial regulatory affairs activities and quality oversight for the entire Ipsen portfolio marketed in US.
This position is responsible for providing guidance on regulatory affairs activities for Ipsen products under development in US, in collaboration with the head of Global Regulatory Affairs US lead and global therapeutics area leads. The role ensures GxP compliance across US affiliates and that resources and processes meet US regulations.
The Head of US Regulatory Affairs & Quality will serve as a principal regulatory liaison to the FDA for all US affiliate activities during the product lifecycle.
Main Responsibilities / Job Expectations The Head leads a team of 10 to 15, with 2 main direct reports covering regulatory affairs and quality activities.
US Regulatory Affairs Activities
Manage all regulatory commercial activities for marketed products in the US.
Ensure resources and processes support product lifecycle management.
Lead development of compliant sales training, advertising, and literature.
Advise Medical Liaison and Communications teams on regulatory issues.
Oversee regulatory review and approval of promotional materials.
Assess and recommend actions to mitigate regulatory risks.
Manage US regulatory vendors and budget.
US Quality Activities
Oversee GxP activities for marketed and developmental products.
Ensure resources and processes support compliance with US regulations.
Represent US quality within the Ipsen global network.
Harmonize GxP processes between global and affiliate teams.
Regulatory Submission & Stakeholder Management
Collaborate on FDA interactions (INDs, NDAs, MAAs, etc.).
Review clinical and manufacturing documentation relevant to Ipsen products.
Support business development activities, including due diligence and partner interactions.
Work closely with Global Regulatory Affairs to align US market insights.
Ethics & Compliance
Maintain compliance with reporting requirements and laws.
Ensure adequate structures and controls are in place.
Adhere to Ipsen’s ethical standards and SOPs.
Knowledge, Abilities & Experience Education / Certifications:
Degree in life sciences; advanced degrees (PhD, PharmD, MD, MSc) preferred with regulatory and GxP experience.
Experience:
8-10 years in biopharma regulatory affairs or related fields.
Leadership experience in regulatory affairs.
Deep knowledge of US regulations and FDA experience.
Preferred experience in oncology, neurology, or rare diseases.
Languages:
Fluent in English; French is a plus.
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