The Senior Director of North America Regulatory Strategy (NA GRA) will be primarily responsible for the development of US regulatory strategy to advance ***'s Rare Disease and Rare Blood Disorders portfolios of development pipeline candidates and life cycle management of marketed products. Reporting to the Associate Vice President of North America Regulatory Affairs, this individual will work within the Global Regulatory Team to provide strategic input and ensure operational execution of US submission activities for the *** Genzyme Rare Disease portfolio. The individual will be responsible to interface directly with the US FDA as the primary contact for the company for assigned programs and lead a small team of North America Regulatory Leads (NARLs)
Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for Rare Disease and Rare Blood Disorders indications which adhere to US regulatory and company guidelines.
Have an understanding of the competitive environment of the various rare disease indications and support NARLs in developing products that are differentiated and provide commercial value as well as value for the patient
Represent the NA GRA perspective as a member of the project-specific cross-functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents.
Lead the strategic development of briefing materials and prepare teams for US FDA meetings.
Accountable to define document content/strategy to align with US regulator expectations.
Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs.
Represent *** at US FDA for assigned projects.
Work with the NA labelling strategist, Global Regulatory Team Leads, and the Global Regulatory Team to develop the US prescribing information.
Work with and participate on multi-disciplinary matrixed teams to successfully meet project US regulatory deliverables while adhering to regulatory requirements for programs and products.
Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
Participate in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.
Function as a player/coach with an ability and willingness to perform dossier/submission management tasks and develop a high level regulatory strategy for assigned projects.
Supervise, and/or coach mentor, junior staff supporting regulatory team.
Ensure compliance with all regulatory and internal policies
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
Direct interaction/negotiation with regulatory authorities (e.g. FDA)
Ability to motivate and lead others
Team player, ability to work well within cross-functional teams and in a multicultural/multinational environment
Excellent oral communication and writing skills
Change management/ change enabler: embraces the challenges of a fast-changing environment
Generates innovative solutions in work situations, trying different and Client ways to deal with work problems and opportunities
Excellent operational skills
Unquestionable ethics, professional integrity, and personal values consistent with the *** values
Source: Job Diva – Job Listing