\\n Description g\\xc3\\xa9n\\xc3\\xa9rale

As a major player in consumer health and cosmetics, Perrigo is an American pharmaceutical company committed to supporting the health and well-being of consumers through a unique portfolio of market-leading brands.

We\\xe2\\x80\\x99re currently recruiting for our recently acquired entity HRA Pharma Rare Diseases which is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world.

We have over 15 years\\xe2\\x80\\x99 experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing\\xe2\\x80\\x99s syndrome and Adrenal Cortical Carcinoma.

We are passionate about improving the lives of people affected by these conditions. We recognize that people living with rare diseases often have severe and potentially life-threatening disabilities that impact not only their quality of life, but also the lives of those who care for them. Delays in diagnosis, together with the lack of effective treatments are just some of the challenges faced by people living with a rare disease.

We\\xe2\\x80\\x99re looking for a new team member in our Global Scientific Affairs Team as Senior CMC Regulatory & Technical Manager. In this role you will have responsibility for the CMC (Chemistry Manufacturing and Control) regulatory strategy and associated lifecycle management of HRA Pharma Rare Diseases products.

It is a truly global role, supporting all CMC Regulatory activities of the product portfolio, currently with 3 high-profile products with a key focus on innovation, and many exciting and challenging projects.

P\\xc3\\xa9rim\\xc3\\xa8tre du poste

Supervising the CMC Regulatory & Technical team, you will be providing the resources and support necessary to perform the global development, maintenance, and industrial transfer in the timeline defined of our pharmaceutical products.

Main responsibilities

• Management of projects on new products

• Initiate, coordinate, review and ensure the implementation of pharmaceutical development plans and industrial transfers in conjunction with the involved departments, ensuring their technical relevance and compliance with applicable practices, regulations, and guidelines
• Validate CMOs and suppliers\\xe2\\x80\\x99 choices for the implementation of projects, including technical specifications and review contracts and financial proposals framing their missions
• Guarantee the quality of the manufacturing/control processes developed/transferred and the medicinal products manufactured

• Review and approve all technical documentation generated by subcontractors/CMOs during the development or transfer, in particular protocols and development reports, validation of processes and analytical methods, test methods and specifications and stability protocols and reports
• Supervise the production of investigational medicinal products and approve the associated documentation (Master Batch Records, sampling protocols, specifications, etc.)
• Supervise and coordinate the transfer of products from development to the production and/or site transfers as part of continuity plans.
• Participate in risk management and in monitoring and conducting audits of subcontractors and suppliers
• Write, coordinate and maintain the quality (CMC)/technical part of dossiers

• Draw up the quality part of investigational medicinal product dossiers (IMPD, IND) and registration dossiers in line with regulatory strategy defined during development and in accordance with the applicable guidelines
• Draw up Quality regulatory variations for products marketed and maintain existing dossiers (renewals)
• Prepare answers for the authorities on the quality part during all phases of the products lifecycle
• Comply with the requirements of the target regions (EU, US, ROW) and the e-CTD format for MA dossiers
• Ensure filing and archiving of all quality/technical documents submitted and approved in all regions

You will also play an active role in quality management of products by using your technical expertise in processing deviations and complaints, managing requests for changes, and any matters relating to product quality control. You will be participating in the development and implementation of quality systems and tools (pharmaceutical development and product quality control).

Finally, you will help to develop regulatory strategy by defining the right strategy with Regulatory Affairs in line with development plans with a view to securing rapid and beneficial registration of new products. You will also carry out scientific and regulatory watch to keep up to date with changes to the regulations and foresee any Quality (CMC) regulatory variations necessary for existing products.

Exp\\xc3\\xa9rience requise

Holding a relevant degree in Pharmaceutical /Biological/Chemical Science or any scientific discipline, you have at least 10 years of work experience in multinational pharmaceutical or life science companies with relevant CMC Regulatory experience including coordinating CMOs activities and registration and post-approval activities in US, EU and major Intercontinental markets.

Essential skills:

• Ability to write Quality/Technical dossiers
• Knowledge and practical experience of GMP and of a quality system
• Excellent critical thinking, written, verbal and interpersonal communication skills
• Strong leadership skills and proactive decision maker
• High level of autonomy and rigor to work independently
• Fluency in both French & English languages

We are a highly focused and agile company, committed to rare and ultra-rare diseases. By leveraging our strengths, we aim to become a company with truly sustainable growth and, ultimately, one of the most valued companies in rare disease field worldwide, come and join us!

Permanent position with a hybrid work model based in Chatillon, next to metro line 13 & T6 tramway.

At Perrigo we are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team\\xe2\\x80\\x99s differences. Individuals of all ethnicities, religious creeds, sexual orientations, genders, ages, mental and physical abilities are encouraged to apply. TOGETHER, we make lives better.\\n \\n \\n \\n \\n \\n

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