Senior Regulatory Affairs Project Manager M/F/X

Company Description

With sales of €600m and 3,000 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).
We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.

Job Description

Senior Regulatory Affairs Project Manager (Combination Products) M/F/X

(CDI - based in Lyon)

As we are growing rapidly, we are looking for a unique person ready to make a difference and join our Compliance & Regulatory team as Senior Regulatory Affairs Project Manager (Combination Products) F/M/X, based in Lyon (7e).

Within Nemera’s headquarters, you will lead the regulatory & compliance expertise of combination products.

You will report to the Global Regulatory & Compliance Leader and you will work closely with the development team, from requirements through to design, development, industrialisation, quality, covering all aspects from defining regulatory opinions, strategies and supporting quality management plans through to QMS development and process improvement. ​

Job Description :

1. You will collaborate with Regulatory and Compliance Project Managers in building the product regulatory strategy and regulatory impact assessment of changes, linked to the device part and combination products.
2. You will collaborate with development teams and with the production site(s) to ensure correct implementation of regulatory and normative activities of the products and concerned production sites.
3. You will support and guide our customers in their notification procedure particularly in EU, US and Canada.
4. You will collaborate with different teams to contribute to the continuous improvement processes.
5. You will support the Regulatory Team in the preparation, verification and approval, of regulatory documents and collect normative information needed for the submission to the authorities, notified body or customers.
6. Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions.
7. You will collect and interpret elements of the monitored standards, inform product or process managers for the changes, analyze and synthesize gaps and collaborate with other departments of the company to guarantee normative compliance.
8. Support development teams during product-specific normative interactions with external stakeholders, such as regulatory organisms and customers.
9. You will participate in standardization committees and external expert groups in order to understand, anticipate and influence existing or new standards.
10. You will conduct in-depth analyzes of proposed product changes, assessing their impact, evaluating the normative compliance and proposing corrective measures if necessary
11. You will support regulatory team about standard compliance

Qualifications

Requirements:

• Master’s degree or higher in life sciences or sciences (Pharmacist, Master in Regulatory Affairs).
• 8-10 years of experience in Regulatory Affairs field in combination products in a pharmaceutical industry ideally with generic drugs
• Experience in EU, US, Canada and Asia Pacific (Optional) registrations
• Multicultural and interdisciplinary environment experience
• Experience in leading Regulatory & Compliance projects within deadlines and working collaboratively in cross-functional teams.
• Follow and understand quality management system and GMP
• Strong knowledge of regulatory requirements, particularly related to combination product submissions.
• Knowledge and experience in ISO 11608, ISO 23908, ISO 14971
• Knowledge and experience in eCTD (Electronic Common Technical Document) Module 3 CMC, CE certification, Notified Body Opinion process
• Knowledge of the process of medical device design experience in products such as syringes, autoinjectors, pumps is advantage
• Fluent in English (spoken and written); additional EU languages such as French
• Travel occasionally