Job Description

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Job Description

About the role:

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases.The Regulatory Lead is accountable for recommending and implementing regulatory strategy and coordinating life cycle activities across the portfolio of PDT products.

The Global Regulatory Lead, Director, in PDT R&D:

• Serves as the global regulatory lead for one or more projects and and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory support functions.

• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of plasma derived therapies, while ensuring compliance with applicable regulatory requirements.

• Serves as the primary liaison to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities in Japan, the European Union and EEA region, Canada and emerging markets.

How you will contribute:

• Accountable for the creation and execution of global regulatory strategies for assigned programs and ensures the global regulatory strategies for assigned programs are up-to-date.

• Collaborates with EU & Canada, Japan, China and/or other regional counterparts in compiling global regulatory strategies and works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.

• Leads the global regulatory sub team (GRT) and represents the GRT at GPT, cross-functional sub teams and working groups.

• Creates high quality, complaint regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives.

• Accountable for all US FDA submissions and approvals for assigned programs. Works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.

• Leads and manages FDA health authority interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.

• Ensures GRT, GPT, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions. Brings any critical regulatory topics for assigned programs to the regulatory review forum for discussion.

• Ensures accurate, up-to-date reporting of program status and milestones globally through the InterACT system and regulatory dashboard and leverages the Dragonfly visualization tool to highlight any major dsicrepancies for assigned programs.

• May lead regulatory review in due diligence for licensing opportunities.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Strong knowledge of global regulatory requirements for drugs and biologics.

• Ability to function as the lead interface with the US FDA and support regional and local regulatory affairs teams with health authority interactions

• Demonstrated ability to develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities

• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve commercial goals

• Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU, and international markets and versed in the overarching regulatory policy landscape in which biopharmaceutical companies operate

• Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways

Leadership

• Ability to motivate, mentor and manage a diverse team in a matrix environment

• Global perspective with a demonstrated ability to work across functions, regions, and cultures

• Ability to identify potential challenges and opportunities and make recommendations

• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company

• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization

• Invests in helping others learn and succeed

• Able to influence without authority at senior (TET/TET-1) level

Decision-making and Autonomy

• Accountable for acting decisively and exercise sound judgment in making decisions with limited information

• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence

• Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities

• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution

• Develops executable plans and meets budget and deadlines

• Builds a culture of data driven decisions

• Ability to challenge self and others to overcome regulatory barriers and deliver high quality solutions to the business

• Ability to negotiate and influence without authority in a matrix environment

• Crisp decision-making following appropriate consultation, even in times of ambiguity

Interaction

• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU

• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions

• Strong communicator, able to persuasively convey ideas verbally and in writing

• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders

Innovation

• Disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities

• Continuously challenging the status quo and bringing forward innovative solutions

• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team

Complexity

• Delivers solutions to abstract problems across functional areas of the business.

• Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.

• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.

• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity

• Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy

• Resilient and comfortable working through large scale global change management

Minimum Requirements/Qualifications:

• BSc degree preferred and advanced degree a plus. BA accepted

• Minimum of 10 years of pharmaceutical industry experience, with a minimum of 8 years of within a regulatory strategy role with at least 5 years in regulatory strategy and/or a combination of regulatory strategy and equivalent experience

• Plasma or biologics experience preferred

• Preferred experience in reviewing, authoring, or managing components of regulatory submissions

• Strong knowledge of global regulatory requirements and prior FDA interactions/submissions experience

• Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals

• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability

• Must work well with others and within global teams

• Demonstrated leadership skills and ability to inspire colleagues and influence in a matrixed environment

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