Le contenu de ce poste est libellé en anglais parce qu'il nécessite de nombreuses interactions à l’international, l'anglais étant la langue de travail
The CHC France Cough&Cold Regulatory Affairs Lead is in charge of the strategic and operational regulatory affairs activities for a portfolio (drugs & Medical Devices) of core local brands including development and marketed products.
He/She also supports the regulatory strategy for the global brands.
He/She is as well in charge to actively & collaboratively shape the regulatory environment in France.
Key responsibilities include
As a regulatory portfolio owner, is accountable for the development of the registration strategies in France for projects/products within the assigned portfolio.
Is also accountable of the coordination of the preparation and on-time delivery of compliant submissions to the French Regulatory Agencies and for managing responses to Regulatory Agencies questions
Is also accountable of the implementation of the regional & global strategy.
Lead or support the organization of scientific advice meeting with the Health Authorities or any consultation meeting
Participate and validate the promotional and non-promotional materials to ensure full compliance with internal & external guidelines/standards
As a regulatory portfolio owner is directly accountable for the maintenance of the existing portfolio until the initial launch of the products – and then in deep collaboration with the dedicated RA Maintenance Team ensuring alignment on priorities and respect of the timings Work in compliance with Sanofi Quality Documents (QDs) and external procedures
Proactively identifies and communicates to higher management all potential risks and options for issue resolution (e.g. maintenance issues, submissions, etc.)
Regulatory Core Brand Leadership
As a full member of the local Core Brand team, actively and proactively contributes to provide regulatory insights, to help drive and shape the Brand strategy
Development of the registration strategy, working collaboratively with Global & Regional functions and cross functional teams to create project plans that identify opportunities, regulatory risks and mitigation strategies
Provides registration strategy and intelligence for due diligence and business development initiatives
Proposes the strategy for HA Interaction and attend HA meetings as required ensuring that all projects have clearly defined regulatory paths leading to successful filings and approvals
Contribute to the revision and validation of all advertising materials
Support Commercial teams in the launches’ activities
Regulatory Intelligence for the assigned portfolio and the French Regulatory environment especially on Medical Devices.
Empowers to face challenges, make decisions and take actions
Encourages collaboration and communication within and beyond the teams
Strategic & Technical Regulatory Affairs Expertise
Demonstrated success in developing regulatory strategies in OTC and medical devices environments; possesses a strong knowledge of French regulatory requirements including on medical devices. He/she will bring creative & innovative ideas to the table to enable category strategies.
He/she will contribute in shaping the external regulatory environment.
Communication & Influencing:
The successful candidate will possess strong communication, negotiation and influencing skills as demonstrated by his/her successful interactions with Marketing, other Scientific Affairs functions, and Industrial Affairs, enabling him/ her to drive the CHC vision in France for the Category.
Competencies and Personal Characteristics:
High standards of integrity
Strong interpersonal skills
Excellent oral and written presentation skills
Dedicated and persuasive “can-do” attitude
Self-motivated; entrepreneurial spirit
Organizational savvy; be able to work in a highly matrix structure
“Think out of the box” mindset
Good organization skills and rigorous
Minimum 3-5years in Regulatory Affairs with a significant background in an affiliate or at Health Authorities level. Experience in Promotional Materials Validation is a must
Knowledge of medical devices regulation in EU/FR.
Good level in English
Recognized expert in managing matrix teams and partnering with cross functional teams at a highly strategic level.
Please provide your resume in WORD or PDF format together with a motivation letter
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