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Regulatory Manager - Innovative Biologics

Company: Sanofi
Location: Framingham
Posted on: May 12, 2022

Job Description:

(Senior) Regulatory Manager - Innovative Biologics

About the opportunity

Join Sanofi as a (Senior) Regulatory Manager - Innovative Biologics where you will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for development and marketed innovative biologics products. In this critical role, you will have the opportunity to work on diverse cutting-edge projects, provide input into the product strategy, global development/commercial teams and local sites as well as assuring regulatory submissions are on time and high quality.

About Sanofi

Sanofi is the specialty care global business unit of Sanofi, focused on rare diseases, multiple sclerosis, oncology, immunology and rare blood disorders. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.
Our ambition is to be the industry leader in specialty care. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.

About growing with us

In this role you will
Act as the GRA CMC Biologics representative in project / product teams
represent GRA CMC Biologics in Global CMC and Global Regulatory Team(s) and meetings, partners with the leaders of these teams to facilitate successful product development

provide accurate regulatory assessments and expertise input to team recommendations

facilitate together with the CMC teams and regional/local regulatory experts the planning and execution of regulatory actions (submissions, meetings, etc.)

Communicate project plans, status and updates to management

Develop and execute global regulatory CMC strategy for assigned product
Gather and assemble needed CMC source information, regulatory requirements relevant for the product, regulatory intelligence in the field

Develop, align and formulate the global regulatory CMC strategy and write strategy documentation

Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations

Support CMC regulatory risk assessments, and drive contingency planning and mitigation of identified regulatory risks

Manage global regulatory submissions and dispatches of CMC packages for new applications / maintenance-, amendment-, supplement-, response submissions etc.
Plan submissions and CMC dossier/package strategies per the product's global CMC regulatory strategy for CTA/INDs, BLA/MAAs, international MAs, HA meetings, maintenance submissions, change amendments/supplements, commitments, etc.

Determine and gain alignment on the required content for CMC dossiers and timelines

Coordinate and support dossier preparation, review and publishing process in line with project timelines

Manage regulatory databases for planning and tracking of regulatory submissions

Manage CMC related Health Authority liaison and communication
Interact and liaise with FDA, EMA on product and CMC topics, coordinates health authority interactions on CMC topics with international Health Authorities and together with local/regional teams

Under the supervision of senior GRA CMC staff: Lead the Regulatory CMC content of meetings with FDA, EMA, supports Health Authority meetings as SME in international countries

Communicate outcomes of health authority procedures or feedback to teams and management

Track HA communication and questions/responses in regulatory databases

Support compliance requirements and activities
Provide CMC regulatory input to change management processes

Ensure regulatory events are tracked in central databases

Prepare reports on regulatory plans and status for management and development/industrial committees

Support dossier compliance activities, health authority inspections and internal/external audits as needed

About you

Qualifications /Education & work experience
University degree (PhD or MSc) in a life science discipline

Strong background in biologics drug development and manufacture, testing

8+ years' experience in regulated pharma environments (research, development, manufacture or analytics) out of which at least 3 years in a regulatory CMC or quality department or as technical/scientific reviewer at competent authorities

Proven expertise / experience with assessing biologics CMC source documentation, writing/reviewing CMC dossier documents, managing regulatory procedures and health authority interactions

Knowledge of global regulations on Biologics drugs

Previously worked with external collaboration partners and/or CROs/CMOs is a plus

Regulatory certifications preferred

Competencies
Excellent organizational and communication (written and verbal) skills.

Previous experience in an international, matrixed, fast-paced environment is a plus

Proficient in using digital tools (MS Word, Excel, PowerPoint, regulatory databases and document management systems)

Patient- and quality-focused mindset and able to drive a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards.

Inspire your Journey, what Sanofi can offer you :
An international work environment , in which you can develop your talent and realize ideas and innovations within a competent team

An individual and well-structured introduction and training when you onboard

You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully

As a globally successful and constantly growing company, Sanofi provides international career paths as well

This is our Sanofi, Discover yours.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

#GD-SA
#LI-SA

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.

Keywords: Sanofi, Framingham , Regulatory Manager - Innovative Biologics, Executive , Framingham, Massachusetts

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