Regulatory Affairs Manager, Europe (based in Dublin, Ireland)
Join to apply for the Regulatory Affairs Manager, Europe (based in Dublin, Ireland) role at iNova Pharmaceuticals
Regulatory Affairs Manager, Europe (based in Dublin, Ireland)
Join to apply for the Regulatory Affairs Manager, Europe (based in Dublin, Ireland) role at iNova Pharmaceuticals
About INova
iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.
About INova
iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.
The Opportunity
We currently have an opportunity for an experienced Regulatory Affairs Manager, Europe (based in Dublin, Ireland) to join our Regulatory Affairs team on a permanent full-time basis.
Reporting to the Associate Regulatory Affairs Director, Europe, the primary purpose of this position is to manage regulatory regional operational activities (within EU markets) to support to maintain regulatory compliance of iNova’s products throughout the region. In addition, to support business growth and the delivery of iNova’s commercial objectives.
Key Responsibilities
With minimal Line Manager supervision, the incumbent is expected to perform the following:
* Coordinate and/or execute the regulatory operational activities related to new marketing authorizations and lifecycle submissions across the region.
* Ensure labelling maintenance and compliance and support the translation process as required.
* Maintain compliance for all marketing authorisations in Europe, including those held by third parties on behalf of iNova
* Ensure efficient and consistent implementation and use of internal and external regulatory databases and systems.
* Coordinate and supervise change management regulatory assessments in the region, as needed.
* Adoption and alignment of iNova’s regulatory information management system with other organizational systems
* Support cross regional regulatory collaboration and harmonisation to achieve iNova’s business and compliance objectives.
* Support business innovation initiatives assessments and regulatory due diligence for new products as required.
* Provide regulatory support for major commercial expansion projects in the region and support the creation or update of dossiers to enable product registrations and lifecycle submissions.
* Support the Regulatory intelligence regional process, to coordinate action or mitigation plans when required.
* Develop and maintain strong relationships with internal business teams and relevant external parties, and communicate with these parties in a timely and effective manner
* Participate on internal cross-regional or cross-functional initiatives, as appropriate
* Perform other duties or special regulatory projects as assigned.
About You
To be successful in this role, you will possess a recognised pharmacy (preferred), medical or relevant science university degree with a minimum of 4-5 years’ experience in the pharmaceutical industry, with at least 3 years’ experience in European (EU) countries and good pharmacological/ pharmaceutical/ clinical knowledge. Experience in other European countries or clusters is considered a plus.
Other Key Requirements For This Role Include
* Solid understanding of regulatory requirements for medicines, medical devices, and complementary medicines; experience in supplements, cosmetics, and food is a plus.
* Strong knowledge of global regulatory frameworks (MRP, DCP, CP)
* Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in the EU region and how those regulations impact on the development, introduction, manufacture, quality, registration and marketing of iNova’s products
* Good project planning and organisational skills with a high degree of multi-project tasking; ability to handle multiple projects within an active and wide range of health care products
* Effective communicator in matrix environments; able to engage diverse stakeholders.
* Strong interpersonal, influencing, and teamwork skills; able to work independently.
* Fluent in English (written and spoken); additional languages are an advantage.
Additional Requirements / Working Conditions
* Occasional business travel within the EU region may be required.
* Adhere to company values at all times
If you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY! We want you to join us in our pursuit of healthy living!
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Pharmaceutical Manufacturing
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