-
Lead Regulatory Affairs Director
2 weeks ago
Aspartes Pharmaceuticals Cambridge, United States**Position Overview**: · We are seeking an exceptionally talented lead Regulatory Affairs director with a high level of experience in the rare/ultra-rare disease space. The role is centered around providing key insight and regulatory input for the development of a small molecule ...
-
Global Regulatory Affairs Lead
3 weeks ago
Sanofi Group Cambridge, United StatesLocation field must contain 'city, state' or a zip code to perform a radius search (e.g., · Denver, CO · or · City and state must be separated by a comma followed by a space (e.g., · Houston, TX ) · Sanofi Group · Global Regulatory Affairs Lead · in · Cambridge , · Massac ...
-
Lead Regulatory Affairs Director
1 week ago
Aspartes Pharmaceuticals Cambridge, United StatesPosition Overview: · We are seeking an exceptionally talented lead Regulatory Affairs director with a high level of experience in the rare/ultra-rare disease space. The role is centered around providing key insight and regulatory input for the development of a small molecule tre ...
-
Director, Global Medical Affairs Lead
2 weeks ago
Dyne Therapeutics Inc Watertown, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide th ...
-
Director, Global Medical Affairs Lead
2 weeks ago
Dyne Therapeutics, Inc. Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide thera ...
-
Director, Global Medical Affairs Lead
1 week ago
BioSpace Waltham, United StatesJob Details · Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern olig ...
-
Director, Global Medical Affairs Lead
1 week ago
Dyne Therapeutics Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide th ...
-
Takeda Pharmaceuticals Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Takeda Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Principal Regulatory Affairs Specialist
2 weeks ago
Philips Cambridge, United States**Job Title**: Principal Regulatory Affairs Specialist · **Principal Regulatory Affairs Specialist · - Software & Artificial Intelligence (U.S. Hub Based)** · The Principal Regulatory Affairs Specialist · - SW & AI will shape, lead and execute innovative regulatory strategies to ...
-
Executive Director, Global Program Team Leader
2 weeks ago
Sarepta Therapeutics Cambridge, United StatesThis position will be responsible and accountable for leading the Global Program Team (GPT) to create and execute an integrated development strategy which coherently integrates the clinical, non‐clinical, regulatory, medical affairs, manufacturing, commercial, and market access p ...
-
Medical Affairs Lead, Infection
1 week ago
Hoffmann-La Roche Ltd Marlborough, United StatesRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we ...
-
Associate Director, Cmc Regulatory
2 weeks ago
Sarepta Therapeutics Cambridge, United StatesCo-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. · Works as Global Regulato ...
-
Associate Director, Academic Administration
3 weeks ago
Harvard University Cambridge, United States**Job Summary** · The Harvard Graduate School of Design (GSD) educates design, research, and scholarship leaders to make a resilient, just, and beautiful world. The GSD offers degree programs across a range of design disciplines—architecture, landscape architecture, urban plannin ...
-
Technology Access Program Coordinator
3 weeks ago
Somerville Cambridge Elder Services Somerville, United States**Job Title: Technology Access Program Manager** · **Reports To: Chief External Affairs Officer** · **Department: External Affairs** · **FLSA Status: ( X ) Exempt or ( ) Non Exempt** · **( ) Union or ( X ) Non-Union** · **Position Summary**: · The Technology Access Program Manage ...
-
Prc Coordinator
1 week ago
Precision Life Sciences Cambridge, United States**Job Summary**: PRC Coordinator · The US Commercial Regulatory Affairs Promotional Review Committee (PRC) Coordinator is responsible for facilitating the promotional review committee process of assigned products for COMPANYs advertising and promotional materials. The individual ...
-
Vice President, Clinical Development
1 week ago
Bicycle Therapeutics Cambridge, United States**Company Description** · Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA. · **Culture** is key and all Bicycle employees actively embrace and role model our company values: · - We are **A ...
-
Takeda Pharmaceutical Cambridge, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Per Diem Case Manager
1 week ago
Somerville Cambridge Elder Services Somerville, United States**Job Title: Per Diem Case Manager** · **Reports To: Manager, State Home Care Programs** · **Department: Home and Community-Based Services** · **FLSA Status: ☐ Exempt or ☒ Non Exempt** · **☐Union or ☒Non-Union** · **Position Summary**: · The Per Diem Case Manager is responsible f ...
-
Medical Affairs Lead, NA
3 weeks ago
Sanofi Group Bridgewater, United States**Medical Affairs Lead - OTC Brands and HCP Strategy, NA** · **Location:** Bridgewater, NJ · **Remote Work:** Hybrid working model · **Travel Expected:** <10% · **Job Type:** Full time · **About the Job** · _At Sanofi Consumer Healthcare, we have one shared mission - we work pass ...
Global Regulatory Affairs Lead - Cambridge, United States - Sanofi-Aventis Belgium S.A.
Description
Global Regulatory Affairs Lead (GRL)Mission statements
The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's diversified portfolio in order to meet corporate and business objectives.
Decisions are made in alignment with the TA, GBU Head and up to the GRA LT as needed.The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT).
Duties & ResponsibilitiesAccountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well as for life cycle management of products
Responsible for proactively contributing to the Target Product Profile (TPP), ensuring competitive profiles in alignment with the business objectives
Is accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives, and setting clear expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects
The role will supervise, coach, and facilitate a feedback culture within the GRT to develop team performance
The GRL is expected to develop a team of Regulatory Strategists (RS) as appropriate
The GRL is accountable for ensuring alignment and communication internally and externally as "one GRA voice" with TA, GBU Head and up to the GRA LT when needed to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate
Identify opportunities to support the team to identify regulatory acceleration opportunities, take thoughtful risks, accept challenges, and making final decisions on the regulatory success rates and mitigations on behalf of the GRT
The GRL is the single GRA point of contact for the program and represents GRA at the GPT / GBT and internal governance committees
The role is responsible for assessing and interpreting the global regulatory and competitive environments and accountable to ensure that it leverages expertise in commercial competitive intelligence and other parts of GRA (e.g. Regional experts and Regulatory Science and Policy) in order to ensure the most robust strategy possible and is accountable for determining any updates to the regulatory strategy accordingly
Leads development of global HA interaction plan and strategy in collaboration with GRT. Is accountable for the communication of the key outcomes to senior management
Advances the organization's goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned therapeutic area and projects in collaboration with the Regions
Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with GRA Strategy and Business Optimization
Knowledge, Skills & Competencies
Autonomously connects and leverages talent to the advantage of the greater team, with curiosity and openness to diverse perspectives
Creates a safe environment that inspires creativity, innovation, and productivity
Is accountable for creating forward-looking vision, influences the environment that optimizes long-term potential by fostering trust and teamwork
Demonstrates strong business acumen, strong leadership, high level influence and persuasive negotiation skills
Strong scientific acuity applicable to multiple therapeutic areas
Expert strategic thinker with experience making complex decisions and defending difficult positions
Significant leadership experience in developing innovative regulatory strategies supporting the clinical development of drugs and/or innovative biologics products
Recognized expert using appropriate interpersonal skills to build internal networks and autonomously lead complex negotiations with internal and external stakeholders
Exemplary communication skills, specifically excellent oral and written presentation skills
Expert level of organizational savvy; self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
Strong sensitivity for a multicultural/multinational environment
Proven leader of groups and teams
Qualifications
BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred
At least 10-12 years of relevant pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global), in early and late stage development of multiple modalities; experience within regulatory CMC not directly applicable
Demonstrated expert regulatory strategic experience and understanding of the regulatory environment to develop regulatory strategies
Previous experience working on regulatory due diligence activities and in a business alliance environment
Demonstrated experience working strategically within a sophisticated, business critical and high-profile development program
Direct experience formulating the regulatory position in collaboration with the GRT and defending innovative regulatory strategies at Global Project Teams or equivalent forum
Extensive experience in leading health authority interactions in major markets
Strategic regulatory leadership expertise with experience in developing and implementing successful regulatory strategy and with preparation of at least one (s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority within a major market (e.g.
US, EU, CN, JP)Previous demonstrated experience of global regulatory drug development to at least one major regulatory approval within a major market (US, EU) including leading the regulatory strategy, response team, and labeling negotiations
Previous experience in leading global Health Authority interactions
Significant project leadership experience
Significant experience in managing people both directly or in a matrixed organizational structure
Direct experience with change management/change enabling: leads teams with a solution-oriented mindset in a fast-changing organizational and external regulatory environment
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.
#GD-SA#LI-SA
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 ourALL IN video
and check out our Diversity Equity and Inclusion actions at
#J-18808-Ljbffr
