Regulatory Affairs Project Manager F/M/X

Regulatory Affairs Project Manager F/M/X

• Full-time
• Employment Classification: Cadre
• Nemera Department: Global Quality & Regulatory

With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering a broad product portfolio that includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built long‑lasting, strong relationships with leading global pharmaceutical companies by providing high‑quality development, industrialisation and manufacturing services. Nemera develops and manufactures its own IP product platforms and also offers fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the U.S., France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).

We are looking for a unique person ready to make a difference and join our Regulatory Affairs team as Regulatory Affairs 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 (Parenteral and ICO products) and 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

• Collaborate with development teams and production site(s) to ensure correct implementation of regulatory and normative activities.
• Be in charge of the resources assessment needed for regulatory and normative activities under ownership and product platform.
• Collaborate with different teams to contribute to the continuous improvement processes.
• Prepare, verify, approve, submit regulatory documents and collect normative information needed for the submission to authorities, notified bodies or customers.
• Participate in drafting, verifying and approving plans and verification reports from internal or external laboratories concerning products under ownership.
• Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions.
• Collect and interpret elements of monitored standards, inform product or process managers about changes, analyse and synthesize gaps and collaborate with other departments to guarantee normative compliance.
• Summarise regulatory and/or normative requirements.
• Support Insight teams during product‑specific normative interactions with external stakeholders, such as regulatory organisms and customers.
• Participate in standardisation committees and external expert groups to understand, anticipate and influence existing or new standards.
• Conduct in‑depth analyses of proposed product changes, assess their impact, evaluate normative compliance and propose corrective measures if necessary.

Requirements

• Engineering degree or equivalent.
• At least 5 years of professional experience.
• Background in combination products or medical devices industry in a multicultural and interdisciplinary environment.
• Knowledge and experience in eCTD (Electronic Common Technical Document) Module 3 CMC, CE certification, Notified Body Opinion process.
• Experience in leading Regulatory & Compliance projects in transversal projects.
• Experience in quality management system and GMP.
• Knowledge of 21 CFR part 820, ISO 13485, MDR 2017/745, ISO 14971.
• Knowledge of ISO 11608 and ISO 23908 are optional.
• Knowledge of the process of medical device design.
• Good English speaking and written skills.
• Effective interpersonal skills with ability to work in a team or independently.
• Ability to multi‑task and manage priorities with effective organisational and time‑management skills.
• Demonstrated flexibility and adaptability.
• Highly motivated with a proactive approach to learning and problem solving.
• Analytical and synthetical skills.

Competences

• MDR 2017/745.
• Generic drugs.

Languages

Fluent in English (the company language).

Nemera is an equal opportunity employer. We review all qualified applications, including those of people with disabilities.