Regulatory Manager - Innovative Biologics
Company: Sanofi
Location: Framingham
Posted on: May 12, 2022
Job Description:
(Senior) Regulatory Manager - Innovative BiologicsAbout the
opportunityJoin 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 SanofiSanofi 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
usIn 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 neededAbout
youQualifications/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 preferredCompetencies
- 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 wellThis 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-SAAt 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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