Sr. Regulatory Affairs
hace 2 semanas
The Aixial Group is seeking a Sr. Regulatory Lead for this client dedicated opportunity with 8 years of experience in Regulatory Affairs. Remote based in Spain or Portugal.
Contribute to the development of the regulatory strategy for the respective portfolio, working collaboratively with the global regulatory office community and cross functional teams to create project plans that identify opportunities, regulatory risks, and mitigation strategies
Define regulatory pipeline strategies in alignment with the business strategy including early-stage operational responsibilities
Provides regulatory strategy and intelligence for due diligence and business development initiatives
Proposes the strategy for HA Interaction and attend HA meetings as required ensuring that all projects have clearly defined regulatory paths to deliver, and milestones are met leading to successful filings and approvals
Accountable for the development of the global regulatory strategies for projects/products within the assigned portfolio, in close collaboration with Regional Scientific Affairs teams.
Be a strategic partner for and work closely with the Scientific Innovation team for their sub-category & align with them on prioritized innovation projects
Accountable of the coordination of the preparation and on-time delivery of compliant submissions to Regulatory Agencies and for managing responses to Regulatory Agencies questions
Accountable of the follow up of the implementation of the global strategy with regulatory affairs in affiliates.
Ensures timely execution of agreed regulatory milestones for the development projects
Develop submission strategy and participate in the organization of scientific advice meeting with the Health Authorities
**Requirement**:
PharmaD Pharmacist - if not at less 8 years of expereince
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