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Confidential
Indianapolis, IN, United States
Vice President, Regulatory Affairs About the Role The Company is in search of a Vice President, Regulatory Affairs to spearhead the development and execution of global regulatory strategies for its innovative therapies. The successful candidate will be at the forefront of shaping the regulatory roadmap, engaging with authorities such as the FDA and
Job Source: ConfidentialJ&J Family of Companies
Indianapolis, IN, United States
J&J Family of Companies Senior Regulatory Affairs Specialist Indianapolis , Indiana Apply Now Senior Regulatory Affairs Specialist - 2406193618W Description Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if appro
Job Source: J&J Family of CompaniesConfidential
Indianapolis, IN, United States
Vice President, Regulatory Affairs About the Company Innovative biotechnology company specializing in Alzheimer's disease therapeutics & diagnostics Industry Biotechnology Type Public Company Founded 1996 Employees 51-200 Categories Biotechnology Pharmaceuticals Academic Research Health Care Medical Care Medical Conditions Therapeutics Medical Diag
Job Source: ConfidentialRoche
Indianapolis
Roche 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 embrace individuality and share a passion for exceptional care. Join R
Job Source: RocheWM
Indianapolis
**Why work for WM?** Stability. Growth Opportunities. People-First Culture (m.com/us/en/inside-wm/who-we-are) . **About the Regulatory and Compliance Manager Role** The Regulatory and Compliance Manager for WMSS PharmEcology Services is responsible for leading and managing all aspects of auditing, improving and sustaining the PharmE state-specific
Job Source: WMActalent
Indianapolis
Great Opportunity to Join a Growing Team! Long-Term Opportunities! Competitive Pay Requirements: + 3+ years of Clinical Research Regulatory experience REQUIRED + Oncology experience preferred Responsibilities: + Responsible for submission of research protocols and other required documents/components to the FDA for investigational new drug (IND)/inv
Job Source: ActalentTakeda Pharmaceuticals
Indianapolis
By 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 submit in my employment application is true to the best of my knowledge.
Job Source: Takeda PharmaceuticalsTakeda Pharmaceuticals
Indianapolis, IN, United States
By 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 submit in my employment application is true to the best of my knowledge.
Job Source: Takeda PharmaceuticalsIndianapolis, IN, United States
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Principal Regulatory Advisor, Global Regulatory Affairs, Innovation, Pharmaceuticals
The Regulatory Advisor will lead global regulatory strategy development, evaluate early and late phase data, and collaborate cross-functionally to create effective development programs for pharmaceutical products. They will also oversee regulatory strategies for product registration, commercialization, and life cycle management, as well as evaluate scientific information for potential acquisitions and represent the company in external organizations. Additionally, they will serve as an internal technical and regulatory resource for existing products to support business affiliates and market access efforts.
Your Responsibilities:
Design and develop creative global regulatory strategy and technical regulatory documents based on interpretation of both regulatory and scientific information
Possess knowledge of and compliance with relevant laws and regulations, and global policies and procedures
Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers and maintaining positive relationships with those parties.
Serve as a resource to development teams and the commercial organization to actively address informational needs, including global and regional promotional material review.
Lead the delivery of compliant commercial labels during the pre-launch phase across major geographies (EU/US), ensuring timely market access and regulatory compliance.
What You Need to Succeed (minimum qualifications): Education : Minimum master's degree; DVM or PhD highly desired
Required Experience : A minimum of 5 years of experience in animal health industry (companion animal health preferred)
Top Skills Needed: Regulatory affairs experience, and understanding of the animal health industry and the animal drug development process
What will give you a competitive edge (preferred qualifications): More years of experience in the industry
DVM or PhD
Strategic thinking and ability to design and develop innovative global regulatory strategies
Effective collaboration and skills in collaborating with cross-functional teams
Additional Information: Travel: Expected travel is up to 20-25%
Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Email Alert for Principal Regulatory Advisor, Global Regulatory Affairs, Innovation, Pharmaceuticals jobs in Indianapolis, IN, United States
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