Sanofi Hiring for CHC – Core Labelling Operations Manager (M/F) Job at Gentilly, LA Full Time

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l’anglais étant la langue de travail.

KEY RESPONSIBILITIES

• Provide peer support or vendor oversight on routine labeling operations activities/projects (e.g. timely dispatch of global labeling update and related supporting documentation to worldwide affiliates and relevant Business partners; support Core Labeling Manager to ensure compliance of the labelling documents to regulations, quality and company standards)
• Act as the Business Subject Matter Expert on the use and development of current and new tools, technologies and processes to support efficient global labeling development or update, and worldwide submissions and approvals
• Contribute to the development of continuous improvement of business practices
• Advocate for new labeling initiatives contributing to the shift from document to data labeling management
• Ensure compliance monitoring and oversight of labelling changes including compliance report of Key Performance Indicators (KPI) to management and QPPV office in close cooperation with Quality and involved functions
• Represent Global labeling operations in assigned project taskforces, launch preparation
• Perform other regulatory labelling duties, as required (e.g., SDEA management, document preparation for regulatory inspections/audits)

PROFILE

Knowledge & skills

• Highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professionalism
• Knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products; knowledge of labeling requirements; proven ability to lead and develop direct reports; organizational and networking skills; and ability to coordinate discussions across all levels of the company to reach resolution on labeling topics
• Ability to assess complex issues and propose viable solutions
• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
• The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals
• Proficient in International Regulations, Guidelines, Good Practices pertaining to the pharmaceutical industry standard and practices

Interactions

• Internal: Science Affairs regulatory teams (corporate and affiliates), Global Pharmacovigilance, Global Supply Chain, Packaging artwork team
• External: Health agencies, vendors

Other 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
• Collaborative team player in a fast-paced and innovative environment
• “Think out of the box” mindset

Formal Education and Experience Required

• Bachelor’s degree in Life Sciences field or Pharmacy preferred
• 5+ years experiences in Pharmaceutical Industry (e.g. Regulatory Affairs, Clinical, Pharmacovigilance, Packaging or Quality Assurance)
• Previous experience in data analysis/performance, publishing and/or EU/US packaging and/or labelling activities is an asset
• Experience in a Consumer healthcare product and strategic development environment is preferred
• Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities
• Ability to act as a Very good organizational and communication skills
• Proficiency in Excel, Word and PowerPoint
• Computer and IT systems experience
• Fluent English (oral and written), professional level required

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.