Job title : Regulatory Strategist, Associate Director - Vaccines
Location: 1. Bridgewater 2. Swiftwater (partly remote working)
Job Type: Permanent, Full-time
About the job
The team is involved in developing and executing regulatory strategies for influenza vaccines in post marketing and in life cycle development stages to support the Flu Franchise business, driving the growth of the Vaccines Global Business Unit. The seasonality of influenza disease and the challenges associated to the regulatory strategies to be developed make the difference.
The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Flu Global Regulatory Lead.
As a key member of the Global Regulatory Team, the Regulatory Strategist is the strategic partner to contribute to the definition of the global regulatory strategy for assigned products, to enable and drive its execution in US, EU and worldwide countries, including Health Authority interactions.
The Regulatory Strategist provides regulatory expertise to the Global Regulatory Team and cross-functional teams to ensure the delivery of business objectives.
The Regulatory Strategist (RS) enables the Global Regulatory Lead (GRL) to provide regulatory position to support business needs, as well as the regulatory team members to provide the necessary information for their responsible accountabilities.
The RS liaises with clinical, medical, commercial, supply functions, and other internal business stakeholders to enable successful regulatory outcomes.
The RS contributes to the development of a harmonized regulatory voice for providing strategic input through participation in appropriate governance committees and forums at the direction of the GRL.
The RS may represent Global Regulatory Team strategic position on behalf of the GRL at regulatory forums/committees at request of GRL.
The RS serves as point of contact with Health Authorities for vaccines in his/her remit in US.
The RS contributes to the development of global Health Authorities interaction strategy in collaboration with the regulatory team members, attends and may lead Health Authorities meetings, and leads the team through meeting preparations.
The RS identifies regulatory risks and proposes mitigations.
The RS contributes to the development of Global Regulatory Project Strategy and ensures alignment with the core product labeling for vaccines in his/her remit.
The RS participates in the development and monitoring of the global regulatory environment.
The RS leads submission team or regulatory sub team to ensure regulatory filings meet the project timelines for product launch (e.g. annual strain variation submissions for Northern and Southern Hemispheres).
The RS may lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
The RS contributes to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc).
The RS supports operational and compliance activities for assigned regulatory deliverables and develops regulatory submission planning, including submission tracking in the electronic document management system.
Knowledge, Skills & Competencies:
Proactively contributes with curiosity and openness to diverse perspectives.
Understanding of clinical development of drugs, biological products. Vaccines is a plus.
Demonstrates business acumen, leadership, influencing and negotiation skills.
Effective communication skills, specifically strong oral and written presentation skills.
Ability to work in electronic document management systems, e.g., Veeva Vault is a plus.
Demonstrated ability to handle multiple products/deliverables simultaneously.
Strong sensitivity for a multicultural/multinational environment.
Experience & Education:
BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience, or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.
Significant US regulatory expertise required.
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