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Sponsored by DesignlabJob Title: Manager, Regulatory CMC
Location: Morristown, NJ
Grade: L3-1
Hiring Manager: Jason Lande
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.
Mission
Responsible for leading the authoring of CMC regulatory documentation to support new development & Life Cycle Management projects and Commercial products.
Act, using advanced knowledge of CMC dossier strategy, as lead author and creator of content from CMC source documentation as needed for registrations and technical reports.
Interface with broader Sanofi teams in Global Regulatory Affairs (GRA), Manufacturing and Supply (M&S) sites and External Manufacturing for outlining needs for change control assessments and dossier content, recommending to GRA table of content outlines for CMC submissions.
Support these activities for submissions to global health authorities (i.e. FDA, EMA, Health Canada, and various ROW Markets).
Assess progress made against dossier projects timelines and project targets adapting workplans and strategy in order to reach individual or team goals.
Work with customers in GRA, M&S and R&D to assess their needs and enact solutions in the work environment to assure cooperation.
Helps in the development of regulatory strategy for successful registrations and provide answers to questions received from regulatory authorities.
Propose strategies for continuous improvements in CMC dossier activities to deliver efficiency gains.
Works closely planning activities, with CMC Project Managers and Directors, specifically supporting details for CMC dossier activities.
Acts as team representatives on CMC sub-teams and support MSAT on select Global Project and Industrial teams.
Coordinates dossier writing work plans for post-approval projects with M&S External Manufacturing and Sites where support is provided.
Responsible for guiding the writing support team on technical CMC aspects for the documentation as well as helping align project priorities.
When M&S Regulatory CMC is the main component of the project, the Manager takes a leadership role of a multidisciplinary project team driving key deliverables and reporting to management.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Provides regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance.
Supports the oversite of contract staff and planning of resource needs for writing activities of the BW MSAT team.
Authors and compiles CMC dossiers for new NDAs and NDA supplements, annual reports, INDs, and DMFs for assigned products in eCTD format.
Works closely with quality, manufacturing, Global Regulatory Affairs and technical staff throughout Sanofi worldwide locations and external manufacturers to communicate, coordinate and track required documentation in support of post-approval CMC activities of the assigned drug products.
Contributes to R&D, LCM, M&S, CHC and Industrial Development projects by supporting CMC technical aspects and sub-teams.
Ensures all dossiers are in compliance with appropriate SOPs, guidance’s, GXP and ICH guidance’s and maintain up to date knowledge.
Communicates with Quality and Manufacturing site teams to request necessary content and documentation for regulatory submissions.
Develops and maintain skills required for dossier related software systems used and included in regulatory filings.
About You
Knowledge, Skills, and Competencies:
Excellent Chemistry, Manufacturing and Controls (CMC) technical writing and communication skills with a background in pharmaceutical development, manufacturing, regulatory writing, or quality control/quality assurance.
Knowledge of CMC development and / or manufacturing / quality control.
Experience with serving on multidisciplinary project teams.
Expertise with MS Office, Word, Excel and electronic document management systems is crucial.
A working knowledge of cGMP’s is desired.
Be highly organized, self-motivated, and able to manage multiple priorities.
Have the capacity to be productive with very little supervision.
Excellent interpersonal communication and collaboration skills are required.
Knowledge of the US regulatory processes is necessary and exposure to non-US regulatory activities is desired.
The ability to communicate using oral and written skills with an excellent knowledge of the English language and have the capacity to be productive with very little supervision.
Excellent interpersonal communication and collaboration skills are required.
Qualifications:
5-7 years’ experience in a pharmaceutical environment including not less than 4 years of experience with CMC regulatory related activities.
BS/BA or MS or PhD from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
Experience in pharmaceutical project management where CMC and / or manufacturing activity was the focus. Working knowledge of a wide variety of pharmaceutical dosage forms and processes.
Experience and familiarity with US and International regulatory submissions and knowledge of the Global regulatory processes.
Experienced with change control systems and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for IND/AR/CBE/PAS/NDA//MAA/BLA/ANDA submissions.
Creation of CMC technical reports
Worked with multidisciplinary teams in the bio-pharmaceutical industry.
Excellent communication and technical writing skills. Negotiation skills a plus.
Be highly organized, self-motivated, and able to manage multiple priorities.
In-depth knowledge of USP/Eu. Ph. and Code of Federal Regulations (CFR). Working knowledge of cGMP’s
Worked with writing templates and template tools
Experience with Electronic Document Management Systems (ie. Documentum based or similar systems) and standardized templates
Why Choose 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.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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.
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 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!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$108,750.00 - $157,083.33All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
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