CMC Regulatory Manager, External Manufacturing CHC, ASEA & AMET

Position Title: CMC Regulatory Manager, External Manufacturing CHC, ASEA & AMET

Job Location: Egypt

Job Type: Permanent, Full time

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as CMC Regulatory Manager, External Manufacturing CHC, ASEA & AMET within our Supply chain team, will be to Manage the CMC regulatory activities within the scope of External Manufacturing CHC AMET (Africa, Middle East & Turkey), ASEA (Southeast Asia, South Korea, Hong Kong & Taiwan) & AU (Australia) & in coordination with other Regulatory Affairs teams (Global Regulatory Affairs CMC, local Regulatory Affairs, Regional Regulatory Affairs) and the third-party manufacturers located in the region

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our ambition is to enable better self-care for individuals and communities, while also contributing to a healthier planet. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Main Responsibilities:

• This position will report to Lead, CMC Regulatory, External Manufacturing CHC AMEA & China  
• Serve as functional Regulatory CMC representative of the Products manufactured by third-party manufacturers.
• Ensure the compliance of the products to the local regulations.
• Support CMC/RA key-point within the frame of the site transfer and new product developments (NPD)s.
• Participate in Project team and support technical task force meetings on RA/CMC related activities.
• Any ad hoc tasks assigned by the reporting manager.

Maintain the product licenses in compliance with the local requirements:

• Life Cycle management: preparation of the Module 3 CTD dossiers as per the applicable regulation for renewals, new registrations, responses to the Health Authorities.
• Regulatory Compliance: gap analysis V.S the current dossiers and V.S the current ICH/ASEAN Guidelines.
• Regulatory variations preparation by using the regulatory tool Veeva.
• Change Control management: preparation of change control request form (CCRF), quality/regulatory assessment.
• Elaborate the regulatory strategy with Global Regulatory Affairs and local affiliates.
• Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
• Make quality regulatory decisions, balancing risks and benefits.
• Coordinate with Global Regulatory Affairs CMC, Sanofi affiliates local Regulatory Affairs to ensure timely and accurate submissions to Regulatory Authorities.

Is the key-point for all CMC RA topics within the scope transfer project  

• Collect the registered information from all markets.
• Collect the site documentations (batch records, QC working instructions, stability reports, batch analysis) from the sending site necessary to perform the gap analysis.
• Identify as early as possible, the required documentation and any content, quality and/or time-line issues. Negotiate the delivery of approved technical source documents in accordance with project timeline.
• Perform the variation record card (VRC): gap analysis of the current dossier V.S the donor site V.S the receiving site.
• Consolidate the regulatory strategy with the affiliate or the Global RA to submit the site change.
• Coordinate with the receiving site the specific activities to fulfil the requirements for each market such stability studies, dissolution, BE study, etc.
• Preparation of the CMC sections based on the documents provided by the third-party manufacturer.
• Formatting of the CMC modules as per the Sanofi requirements and creation of the CTD documents in Veeva.
• Response to MoH questions related the quality module of the dossier.
• Follow up of the regulatory status of the submissions.
• Provides RA CMC support to other Sanofi sites who will receive the products from third party manufacturer.

Is the key-point for all CMC RA topics within the scope of new product development 

• Support the CMC RA aspect of product due diligence.    
• Share regulatory requirements to third party manufacturers.
• Review dossier to ensure compliance of dossier with local legislation where the product is to be marketed
• Co-ordinate with global, regional and local teams for the dispatch of the dossier
• Support response to queries for deficiency letters received.
• Provide regulatory training to the third-party manufacturers.
• Provide regulatory KPIs and regulatory highlights to the reporting manager on a monthly basis.
• Any ad hoc activities as specified by the reporting manager. 

About you:

Qualifications:

• Preferably 10 years working experience in CMC regulatory affairs.

Technical skills:

• Writing of technical reports,
• In depth knowledge of ICH Guidelines and local market regulations,
• Experience in providing CMC support of new and/or marketed pharmaceutical/nutraceutical products
• Ability to provide input, guidance and recommendations in the preparation of the dossiers from different sources to give uniformity of filing in each country.

Soft skills:

• Ability to work in a matrix organization
• Good team spirit and familiar with project development through cross-functional activities
• Strong organizational and negotiation skills
• Ability to establish and maintain good regulatory networking internally and externally
• Strong interpersonal and communication skills (writing & verbal) with excellent command of English,
• Pro-active and well organized with good sense of responsibility
• Balanced Judgment / Risk based approach
• Analytical thinking, hands-on troubleshooting style

Education:

• Preferably Degree in Pharmacy / Pharmaceutical Science / Related Science

Why choosing us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Pursue Progress. Discover Extraordinary.

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 happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch ‘One day at Sanofi’ and check out our Diversity Equity and Inclusion initiatives at sanofi.com!

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 happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!