Oncology Global Regulatory Affairs Lead

Parexel International Corporation

USA - Any Region - Home Based

Excellent opportunity for an experienced Oncology Global Regulatory Affairs Lead to bring your talent, excellent communication skills, strategic mindset, and regulatory expertise to Parexel Consulting as a Senior / Principal Regulatory Affairs Consultant! This is tremendous opportunity to work alongside one of the largest global healthcare companies dedicated to improving the quality of life, so people can do more, feel better, and live longer.

In this highly visible role, you will partner closely with a large multinational pharmaceutical company to ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both Client process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.

Responsibilities and Accountabilities (include expected deliverables, managerial and leadership responsibilities, and performance standards) Accountable to Client’s Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within the Client’s internal teams and representing the Client with at least the local regulatory agency Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data Lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for: Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally Implementation of the regional strategy(s) in support of the project globally Lead regulatory interactions and the review processes in local region Ensuring appropriate interaction with regional commercial teams in local region Ensuring compliance with regional requirements at all stages of product life from C2MD Ideally able to advocate persuasively approaches to senior leaders in Client and in Health Authorities Capable of providing assessment of potential in license molecules Qualifications

Competencies and Capabilities (include key high-performance behaviors) Excellent communication skills, ideally in writing and verbally Proven ability to deliver key communication with clarity, impact, and passion Commands attention and interest through use of appropriate communication techniques Proven ability to foster strong matrix working Capable of facilitating groups of individuals to work together on creating solutions Ability to lead change and communicate difficult messages Able to implement plans and hold self and team accountable for delivery of short- and medium-term goals Proven ability to build strong personal networks, within Client and use them to secure appropriate support and outcome for a project Developing an external network Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context Proven ability to make sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints In doing so, the job holder will use all available sources of information and weigh benefits and risks before making important decisions Shows a constant focus on improving performance and excellence in all tasks Challenges and questions ways of working to seek improved process Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets Experience, Skills and Specialized Knowledge Required (include required and preferred education and experience) Bachelor’s degree or preferably PhD in biological or healthcare science Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence Proven experience of leading regional development, submission and approval activities in local region(s) Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area Ideally also a significant external network at least into other pharmaceutical companies and recognized internally and externally as an expert broadly or in specific areas of regulatory affairs

This role may require <15% travel to client location in the future as needed

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

2022-06-14 00:05:19

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