Regulatory Affairs Manager, Aptar Pharma Prescription Division
Create, Innovate, Deliver Solutions! This is what you can expect from a career at Aptar Pharma. We have an immediate opening for a Regulatory Affairs Manager within our Prescription product division. Aptar Pharma is part of Aptar Group, a global leader of dispenser systems for the packaging industry. Aptar Pharma has been setting the standard for the drug delivery industry for decades and continue to break new ground providing innovative drug delivery devices, components and services, enabling the success of our clients.
If you are eager for new challenges in a fast-paced growing Company, we are the next step in your career!
What You Will Do at Aptar Pharma:
As a Regulatory Affairs Manager, you will be help drive the management of worldwide regulatory intelligence in support of Aptar Pharma’s customers and the successful placement of drug delivery devices on global markets that meet safety and performance expectations for patients.
This position strengthens Aptar Pharma’s Regulatory Affairs (RA) capabilities in addressing a substantial increase of regulatory requirements. This position will partcipate in the global integration of Regulatory Affairs. The Global RA team’s strategy is attaining excellence in regulatory support to Aptar Pharma’s innovation and R&D, in the management of its regulatory dossiers and in its relationships with Health Authorities globally.
The Regulatory Affairs Manager will be part of the North American RA Team and will:
- Manage the regional regulatory intelligence linked to the US requirements on drug-device combination products,
Manage the global regulatory intelligence linked to specific fields of regulatory expertise,
- Build and manage the global products’ regulatory strategies and plans for the Prescription division,
- Provide regulatory support to the Innovation and R&D teams, so that the products are developped and maintained in accordance with the defined regulatory strategies,
- Ensure the link with the RA Team’s operational unit in charge of the preparation and maintenance of the regulatory dossiers, and of their submission to Health Authorities and provision to clients,
- Have direct communication and remain in direct contact with Health Authorities and Prescription division’s clients to ensure excellent regulatory support,
- Contribute to the management of process and methodologies supporting all RA activities,
- Work internally in close interaction with RA Teams of the other Aptar Pharma segment, with Quality and r&D teams, with Sales, Operations, Marketing teams, etc…
- Work externally in close interaction with clients, Health Authorities, Industry Groups, etc…
What Aptar Pharma Is Looking For:
- A Bachelor’s degree in biomedical engineering, pharmacology,chemistry, pharmaceutical or biological sciences or equivalent.
- At least 5 years of experience as an RA professional in the medical device industry, combination products or medicinal products industry, with strong skills and business accumen.
- RA experience with integral drug-device combination products in EU and US a big plus!
- Knowledge and experience with pharmaceutical container-closure systems, at least in EU and US.
- Understanding/experience of Orally Inhaled and Nasal Drug Product dose forms.
- Experience in dealing with international life science companies (pharmaceutical companies, combination products manufacturers, suppliers and service providers).
- Knowledge in other specific fields of expertise preferred, such as: extractables/leachables, medical devices up to class IIa, pharmaceutical and/or medical device quality systems and GMP
- Proven ability to effectively interact with Health Authorities external interest/Industry/standardization working groups and other key stakeholdres.
- Fluent in local language
- Possess excellent written and verbal communication skills
- Effective organizatioal skills and the ability to integrate into cross functional and multi-cultural environments, driving and contributing to complex topics and strategies
- Customer focus oriented, providing direct support and expertise to internal & external customers
- Possess strong team spirit and an integrity mindset