Regulatory & Compliance Project Manager F - M - X H/F - 69

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.Regulatory & Compliance Project Manager F/M/X

(CDI)

We are looking for a unique person ready to make a difference and join our Compliance & Regulatory team as Regulatory & Compliance Project Manager F/M/X, based in Lyon (7e).

Within Nemera's headquarters, you will lead the regulatory & compliance design projects of drug delivery devices. You will report to the Regulatory Affairs Manager of the BU and you will work closely with the development team, from requirements through to design, development, industrialisation, post marketing, quality, covering all aspects from defining regulatory strategies, and supporting quality management plans through to QMS development and process improvement.

Job Description :
- 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.
- You will be in charge of the resources assessment needed for regulatory and normative activities under your ownership and product platform.
- you will collaborate with different teams to contribute to the continuous improvement processes.
- you will prepare, verify, approve, submit regulatory documents and collect normative information needed for the submission to the authorities, notified body or customers.
- Participate in the drafting, verifying and approving plans and verification reports from internal or external laboratories concerning products under your ownership.
- Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions.
- 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.
- You will summarize regulatory and/or normative requirements.
- Support Insight teams during product-specific normative interactions with external stakeholders, such as regulatory organisms and customers.
- You will participate in standardization committees and external expert groups in order to understand, anticipate and influence existing or new standards.
- You will conduct in-depth analyzes of proposed product changes, assessing their impact, evaluating the normative compliance and proposing corrective measures if necessary