CHC Core Labeling Operations Lead

Job description

Job Purpose
The purpose of the Core Labeling Operations Lead is to drive the routine labeling operations activities/projects and to ensure the compliance monitoring and the inspection readiness for the CHC Core Labeling department in close cooperation with Quality and involved functions.

The Core Labeling Operations Lead acts 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 Labeling submissions and approvals including the contribution to the shift from document to data labeling management.

This position is at the Global company level, to support the Global business across Regions/countries.

The Core Labeling Operations Lead will build and maintain strong collaborative relationships with key internal stakeholders including Quality, Regulatory, Pharmacovigilance, Supply Chain, Packaging/Artwork team, and external stakeholders including Health agencies.

Main responsibilities:

The Core Labeling Operations Lead is responsible for:

·  Provide peer support or vendor oversight on routine labeling operations activities/projects (eg. timely dispatch of global labeling update and related supporting documentation to worldwide affiliates and relevant Business partners for Consumer Health Care (CHC); support Core Labeling Manager to ensure compliance of the labelling documents to regulations, quality and company standards).
·  Coordinate regional and local processes for timely and accurate implementation of labeling changes.
·  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.
·  Manage the Labeling Agreements and/or review Safety Data Exchange Agreements (SDEA) as requested, track and monitor compliance to Labeling and/or Safety Data Agreements.
·  Manage CAPA follow-up and ensure inspection readiness for CHC Core Labeling department in close cooperation with Quality and involved functions.
·  Represent CHC Core labeling operations in assigned project taskforces, launch preparation.

In addition, the Core Labelling Operations Manager can be requested to:

·  Participate in writing or update of quality documents;
·  Perform other regulatory labelling duties, as required (e.g., document preparation for regulatory inspections/audits).

Some responsibilities may be region/role specific (such as US Annual report, EU linguistic review process, SPL/drug listing, coordination of EU patient information leaflet readability).

Requirements & Qualifications:

·  Experience :
·  Experienced professional with knowledge of industry trends and experience in driving and implementing Labeling process improvement initiatives.
·  2+ 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 (CHC) product and strategic CHC development environment is preferred.
·  Experience leading and managing matrix organizations.

·  Soft skills :
·  Highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professionalism.
·  Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines.
·  Ability to adapt enthusiastically to organizational change and to changes in job demands.
·  Ability to assess complex issues and propose viable solutions.
·  Ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
·  Excellent oral and written presentation skills.
·  Dedicated and persuasive “can-do” attitude.
·  “Think out of the box” mindset.

·  Technical skills :
·  Knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products;
·  Knowledge of labeling requirements;
·  Proficient in International Regulations, Guidelines, Good Practices pertaining to the pharmaceutical industry standard and practices;
·  Computer and IT systems experience (eg. Veeva Vault RIM);
·  Proficiency in Excel, Word and PowerPoint.

·  Education : Bachelor's degree in Life Sciences field or Pharmacy preferred.
·  Languages : Fluent English (oral and written)

What Sanofi Can Offer You

·  Benefits to enhance your life journey
·  Development opportunities to own your future
·  An open and inclusive environment where you can be yourself
·  Social activities and wellbeing programs to support your life

We chase the miracles of science to improve people’s lives.

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. 

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our commitments.

Pursue progress.

Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles.

So let’s be those people.

Let’s explore more, and share a purpose, as well as our skills. Let’s reinvent healthcare, chase change, and embrace new ideas. Let’s take bigger risks and find better solutions for the people we help.

Let’s pursue progress.

And let’s discover extraordinary, together.

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.