Senior Director, Oncology Regulatory Affairs
Cambridge, Massachusetts, Bridgewater, New Jersey
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The Senior Director, Global Oncology Regulatory Affairs is part of the Sanofi Genzyme Global Regulatory Affairs (GRA) team based in the US. He/she is responsible for developing long and short-term regulatory strategies that impact company’s business objectives.
Specific responsibilities include:
The Senior Director, Global Oncology Regulatory Affairs is responsible for developing long and short-term regulatory strategies for the products under his/her accountability. They will manage a small team of Global Regulatory Affairs Team Leads (GRTLs), and also take GRTL responsibilities for assigned programs.
The role is responsible for the development as well as life cycle management strategies for the assigned project/products. In this capacity, the Senior Director leads the Global Regulatory Team (GRT, consisting of Regions, Regulatory CMC, Regulatory Operations, Labeling) to develop robust regulatory strategies leading to first cycle approvals with optimal labels.
- Represents Global Regulatory Affairs (GRA) as a member of the cross functional Global Project Team (GPT) and provides regulatory input for the project(s) globally. In this capacity, the role is the single point of contact for the business and R&D on regulatory issues for the project.
- Ensures development of robust regulatory strategies for the program and will be accountable for developing and maintaining a regulatory strategy document. The regulatory strategy document includes the overall regulatory strategy and how it will deliver on the Target Product Profile (TPP), regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies.
- Works transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
- Accountable for ensuring that all GRA peer reviews are conducted in a timely manner ahead of key governance meetings and major (issue driven) ad hoc reviews by Sr. Management. The role is also accountable for ensuring that GRA Sr. Management is aware of any major issues with the project, including any changes to risks.
- Represents regulatory position at the internal governance meetings with Sanofi senior leadership.
- Works with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The role will also work with the labeling strategist and regions to develop region specific labels.
- Working with the regions, interacts directly with HAs as needed for the project.
- Working with the cross-functional project team, assesses the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications and/or marketing authorizations.
- Provides regulatory due diligence assessments of new business opportunities as required
- Depending on the program assignment, the role may also serve as the US Regulatory Lead and responsible for developing and implementing the US regulatory strategy. The US lead will serve as the primary FDA contact as needed and will represent the US regulatory position to senior management governance committees as needed.
- 10+ years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 8 years working in regulatory affairs (regionally or globally).
- Experience in other relevant functions will be considered.
- BS in a scientific discipline.
- Recent regulatory experience in Oncology product development. Advanced degree is preferred (MS/PhD/PharmD).
- Experience with least one major marketing application (NDA/BLA/MAA/JNDA etc…), or extensive experience with late stage development/marketed products.
Knowledge, Skills and Other Experience
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
- Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
- Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
- Excellent operational skills including planning, organizing and ability to motivate and lead others.
- Ability to work well within cross-functional teams
- Demonstrates excellent oral communication and writing skills
- Understanding of the Global and U.S. pharmaceutical marketplace and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- Develops collaborative relationships to facilitate the accomplishment of work goals
- Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
- Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
- Can build networks to obtain cooperation without relying on authority
- Strong sensitivity for a multicultural/multinational environment
- Unquestionable ethics, professional integrity, and personal values.
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.
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.
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