(15h Left) Global Regulatory Lead Position Available In Morris, New Jersey

Job Description:

Job Title:

Global Regulatory Lead Location:

Morristown, NJ,Cambridge, MA About the Job Are you ready to shape the future ofmedicine? The race is on to speed up drug discovery and developmentto find answers for patients and their families. Your skills couldbe critical in helping our teams accelerate Progress. The GlobalRegulatory Affairs Lead (GRL) is the fully accountable decisionmaker for the development & execution of creative, thoughtful, androbust global regulatory strategies for their products in Sanofi’sdiversified portfolio in order to meet corporate and businessobjectives. Decisions are made in alignment with the TA, GBU Headand up to the GRA LT as needed. The GRL is the primary interfaceand key strategic GRA partner for the Global Project Team (GPT) andGlobal Brand Team (GBT). We are an innovative global healthcarecompany with one purpose: to chase the miracles of science toimprove people’s lives. We’re also a company where you can flourishand grow your career, with countless opportunities to explore, makeconnections with people, and stretch the limits of what you thoughtwas possible. Ready to get started? Main Responsibilities

• Accountable for leading the development and execution of innovativeand value-added global regulatory strategies and be responsible forformulating the Global Regulatory Project Strategy (GRPS), GlobalSubmission Strategy, and core product labeling in development aswell as for life cycle management of products.
• Responsible forproactively contributing to the Target Product Profile (TPP),ensuring competitive profiles in alignment with the businessobjectives
• Accountable for leading the GRT for fostering teamperformance by aligning team on mission, prioritization,objectives, and setting clear expectations for the GlobalRegulatory Strategy and Plan, including a global labeling strategyfor assigned projects
• The role will supervise, coach, andfacilitate a feedback culture within the GRT to develop teamperformance
• The GRL is expected to develop a team of RegulatoryStrategists (RS) as appropriate
• The GRL is accountable forensuring alignment and communication internally and externally as”one GRA voice” with TA, GBU Head and up to the GRA LT when neededto advocate regulatory position to governance and committees andshares outcomes to GRT and cross-functional partners as appropriate
• Identify opportunities of regulatory acceleration , takethoughtful risks, accept challenges, and making final decisions onthe regulatory success rates and mitigations on behalf of the GRT
• The GRL is the single GRA point of contact for the program andrepresents GRA at the GPT / GBT and internal governance committees
• The role is responsible for assessing and interpreting the globalregulatory and competitive environments and accountable to ensurethat it leverages expertise in commercial competitive intelligenceand other parts of GRA (e.

g. Regional experts and RegulatoryScience and Policy) in order to ensure the most robust strategypossible and is accountable for determining any updates to theregulatory strategy accordingly

• Leads development of global HAinteraction plan and strategy in collaboration with GRT. Isaccountable for the communication of the key outcomes to seniormanagement
• Advances the organization’s goals by participating andtaking leadership roles in professional associations, industry andtrade groups as appropriate for assigned therapeutic area andprojects in collaboration with the Regions
• Accountable forregulatory assessment for Due Diligence activities as applicablethrough the partnership with GRA Strategy and Business OptimizationAbout You Experience/Professional Requirement
• Connects andleverages talent to the advantage of the greater team, withcuriosity and openness to diverse perspectives.
• Nurtures a safeenvironment that inspires creativity, innovation and productivity
• Is responsible for creating forward-looking vision, influences theenvironment that optimizes long-term potential by fostering trustand teamwork
• Demonstrates business acumen, leadership, recognizedinfluence and persuasive negotiation skills
• Scientific acuityapplicable to multiple therapeutic areas
• Recognized strategicthinker with an ability to make complex decisions and willingnessto defend difficult positions
• Direct strategic regulatoryleadership experience in clinical development of drugs and/orinnovative biologics products
• Direct experience using appropriateinterpersonal styles and techniques to build internal networks andlead complex negotiations with internal and external stakeholders
• Highly effective communication skills, specifically excellent oraland written presentation skills
• Organizational understanding;self-motivated and able to work in a highly matrixed structureincluding sharing knowledge with relevant stakeholders
• Strongsensitivity for a multicultural/multinational environment
• Provenleader of groups and teams Qualifications
• BS/BA degree in arelevant scientific discipline required. Advanced degree (PharmD,PhD, MD or DVM or MSc in Biology, Life Science, or related field)is preferred
• At least 12 years of relevantpharmaceutical/biotechnology experience in R D, including atleast 10 years of relevant Regulatory Affairs experience (regionaland/or global), in early and late development
• Demonstrated expertregulatory strategic experience and understanding of the regulatoryenvironment to develop regulatory strategies
• Ability to workstrategically within a sophisticated, business critical andhigh-profile development program
• Experience being accountable fordeveloping and defending innovative regulatory strategies at GlobalProject Teams or equivalent forum
• Previous experience in leadingHealth Authority interactions in major markets
• Strategicregulatory leadership expertise with experience in developing andimplementing successful regulatory strategy and with preparation of(s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefingdocuments and negotiating with a national/regional Health Authoritywithin a major market (e.g. US, EU)
• Experience leadingfilings/registrations and obtaining a regulatory action in a majormarket(s)
• Project leadership experience
• Experience leading ateam and/or developing internal talent Why Choose Us?
• Bring themiracles of science to life alongside a supportive, future-focusedteam.
• Discover endless opportunities to grow your talent anddrive your career, whether it’s through a promotion or lateralmove, at home or internationally.
• Enjoy a thoughtful,well-crafted rewards package that recognizes your contribution andamplifies your impact.
• Take good care of yourself and yourfamily, with a wide range of health and wellbeing benefitsincluding high-quality healthcare, prevention and wellness programsand at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc.and its U.S. affiliates are Equal Opportunity and AffirmativeAction employers committed to a culturally diverse workforce. Allqualified applicants will receive consideration for employmentwithout regard to race; color; creed; religion; national origin;age; ancestry; nationality; marital, domestic partnership or civilunion status; sex, gender, gender identity or expression;affectional or sexual orientation; disability; veteran or militarystatus or liability for military status; domestic violence victimstatus; atypical cellular or blood trait; genetic information(including the refusal to submit to genetic testing) or any othercharacteristic protected by law

GD-SA LI-SA

LI-Onsite vhd Allcompensation will be determined commensurate with demonstratedexperience. Employees may be eligible to participate in Companyemployee benefit programs, and additional benefits information canbe found here.