About this opportunity
Title:
GRA Expert
Company:
Ipsen Innovation (SAS)
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .
Job Description:
WHAT - Summary & Purpose of the Position
• To provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects.
• Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the assigned product/project.
• To execute the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) for assigned region or worldwide.
• Lead operational excellence initiatives within GRA
WHAT - Main Responsibilities & Technical Competencies
• Overall Accountability
Accountable for the flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products.
• Product/Project Leadership
Accountable for the execution of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member:
o Implements regulatory strategy for specific projects under supervision of Therapeutic Area Senior Manager/Director/Senior Director.
o Contributes to the drafting of the regulatory strategy (Global Regulatory Strategy Document)
o Contributes to the data collection supporting building of the regulatory strategy (competitive and regulatory intelligence).
o Gathers, evaluates, organizes, manages and collates information for regulatory dossiers relating to development activities e.g. INDs/clinical trial applications, orphan drug designations, PIP/PSP submissions, NDA/MAA e.g. new and extension/variation etc
o Contributes to review of regulatory dossiers.
o Ensures quality authoring of core administrative parts of submissions
o Ensures adequate planning.
o Coordinates with Global Regulatory Affairs publishing team to ensure appropriate planning, completion of submission request forms, binder creation, publishing and submission (where relevant).
o Ensures that regulatory data are adequately reported and QC ed in the relevant tools / databases through data entry team in a timely fashion (eg Vreg) and that regulatory documentations are tracked/archived in dedicated tools / databases (eg eTMF) Uses a variety of specialist computer applications effectively.
o Ensures that quality and regulatory standards are met
• Operational excellence
o Supports operational excellence initiatives and diverse transversal projects within GRA.
o Contributes to the review of company systems and processes and is actively involved in the implementation of changes.
• Compliance
o Operates according to Regulatory and Ipsen SOPs.
• Reporting
o Ensures adequate reporting of his/her activities and participates to various meeting.
o Supports and voices the regulatory position consistent with the regulatory strategy validated by the management of the regulatory function.
• Ethics and Compliance
o Accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policies
HOW - Knowledge & Experience
Knowledge & Experience (essential):
• First experience in Regulatory Affairs in the pharmaceutical industry or CRO (minimum of 3 years)
• Knowledge of regulatory procedures
• Excellent written and oral communication skills.
• Strong organizational skills.
• Strong interpersonal skills.
• Curiosity.
• Autonomy.
Knowledge & Experience (preferred):
• Knowledge of medical device / drug device combination regulations would be a plus.
Education / Certifications (essential):
• Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
Language(s) (essential):
• English
#LI-MM1 #LI-hybrid
Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 531 comparable Regulatory Affairs roles across 109 biopharma companies.
Salary context
126 of 531 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 531 comparable roles
+ 43 more countries
Seniority mix
417 of 531 peers have a known seniority level
Therapeutic area mix
51 of 531 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.