Job Title: Associate Regulatory Affairs Director I
Career Level - E
Introduction to Role:
Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This role offers the opportunity to work across varied stages and molecules, providing a dynamic and challenging environment that will expand your skills and knowledge.
Accountabilities:
As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval. You will also provide regulatory expertise on procedural and documentation requirements to various teams, ensuring the delivery of business objectives. You may also be responsible for the maintenance of global labeling documents for allocated products and the planning and management of Regulatory and basic Clinical and Non-Clinical publishing deliverables.
Essential Skills/Experience:
Relevant University Degree in Science or related discipline
Minimum 9 years of relevant regulatory experience within the biopharmaceutical industry
General knowledge of drug development
Thorough knowledge of the regulatory product maintenance process
Strong project management skills
Leadership skills, including experience leading multi-disciplinary project teams
Experience managing complex regulatory deliverables across projects/products
Experience working with people from locations outside of India, especially Europe and/or USA
Excellent English written and verbal communication skills
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
Proficiency with common project management (eg MS Project) and document management tools
Ability to work independently and as part of a team
Influencing and stakeholder management skills
Ability to analyze problems and recommend actions
Continuous Improvement and knowledge sharing focused
Are you ready to be part of a dynamic team that's empowered to make quick decisions? Are you curious by nature, ready to dig into challenges to get to the core of a solution? If so, apply today!
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