The role is primarily responsible for providing US regulatory strategic and tactical support for both development and marketed products in the immunology. In this capacity, the Manager/Senior Manager North America GRA will be responsible for providing US regulatory advice for development programs and marketed products working either independently as the North America Regional Lead (NARL) or supporting the North American (NA) Regulatory Lead. Further, the role will represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop and maintain US aspects of regulatory strategy documents.



**Responsibilities:**



+ Support the preparation of regulatory documentation and submission activities to meet business and agency milestones.

+ Create submission plans and manage timelines in MS Project, and document workflow from draft through finalization for US submissions.

+ Prepares routine submissions in compliance with department and regulatory requirements and guidelines. Assists with larger or more complex submissions.

+ Identify risks to timeline and assists the North American (NA) Regulatory lead

+ Work with Regulatory Operations to identify resource requirements and strategies to address overlapping resource demands and rate limiting factors

+ Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed

+ Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.

+ Collaborate within regulatory and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications in the US.

+ Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, and pediatric investigation plans

+ Participate in regulatory research activities, as needed.



**Job Requirements:**



**Education/Experience:**



+ BS in pharmaceutical related scientific field.

+ Minimum 2-5 years of regulatory experience in a biotech/pharma company



**Knowledge and Skills:**



+ Excellent project management and writing skills, as well as a good understanding of the underlying science

+ Experience with preparation of initial INDs, CTAs, amendments, DSURs and meeting briefing documents. Experience with BLA, NDA, or MAA a plus.

+ Understanding of the development of drugs and/or innovative biologics products. Experience in orphan drugs a plus

+ Basic understanding of regulations and guidelines related to drug development and registration is required.

+ Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

+ Independently motivated, detail oriented and good problem solving ability

+ Demonstrated ability to handle multiple projects is required.

+ Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities

+ Excellent communication skills and ability to influence across multiple functions



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



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.



Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.



With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.



Sanofi, Empowering Life

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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