Senior Regulatory Affairs Project Manager M/F/X
Senior Regulatory Affairs Project Manager M/F/X
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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 Nemeras 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 :
- 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.
- 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 support and guide our customers in their notification procedure particularly in EU US and Canada.
- You will collaborate with different teams to contribute to the continuous improvement processes.
- 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.
- 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.
- Support development 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
- You will support regulatory team about standard compliance
Qualifications :
Requirements:
- Masters 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
Soft skills
- Effective interpersonal skills with ability to work in dynamic teams and independently
- Ability to communicate effectively both verbally and in writing and in presenting information concisely to others in a group or one to one setting
- Ability to multi-task and manage priorities with effective organizational and time management skills
- Demonstrated flexibility and adaptability
- Highly motivated with a proactive approach to learning and problem solving
- Analytical problem-solving and synthetical skills
Competences
- Combination products
- Medical devices
- MDR 2017/745
- GMP
- Generic drugs
Languages:
Fluent in English (as it is our company language) French is a plus.
You will be successful here if you are:
Passionate about growing a business
Enjoy working as a team
Proud to make products that improve patients lives
And go the extra mile to deliver on your commitments
At Nemera our patient-first purpose is at the heart of who we are. We foster a culture of care that gives us the power to do whats right for patients customers and our people. As a team were wired for growth. Passionate. High-energy. High-impact.
We are committed to fostering a work environment that values and celebrates difference which is fair and equitable and is enriched by openness curiosity and accountability. Everyone at Nemera has a role to play and Diversity and Inclusion is everyones responsibility. Because when everyone is included Nemera wins!
That is why Nemera is an equal opportunity employer and in accordance with our diversity policy we review all qualified applications including those of people with disabilities.
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group if you want to discover more about Nemera please look at our website
Please send your resume in English
Additional Information :
Our Recruitment Process
We believe in a transparent and straightforward recruitment process to ensure a great fit for both you and our team.
Heres what you can expect:
- CV Review: Upon receiving your CV our Talent Acquisition Team will review it to assess your qualifications for the role.
- Initial Screening: If your profile matches our requirements youll be invited for an initial screening call with a member of our Talent Acquisition Team.
- Interview with Hiring Manager: After the initial screening youll have an interview with the Hiring Manager to discuss your experience skills and fit for the role in more detail.
- Interview with N2: Following the Hiring Manager interview youll meet with the next level of management (N2) for further evaluation.
- HR Manager Interview: The final step involves an interview with our HR Manager to discuss company culture benefits and other HR-related topics.
- Offer: If all goes well youll receive an offer to join our team!
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group if you want to discover more about Nemera please look at our website
Know someone at Nemera We have a Referral Program so be sure to have them submit you as a referral prior to applying for this position!
Chez Nemera nous valorisons la diversit et linclusion et nous nous engageons crer un environnement de travail o tous les employs sont traits avec dignit et respect.
Nous sommes fiers dtre un employeur offrant lgalit des chances et nous encourageons les candidatures de toutes les origines genres orientations sexuelles ges et capacits.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
