Principal Regulatory Affairs Consultant - Team Lead / Director, RA

Fantastic opportunity for a highly experienced Regulatory professional with proven experience leading teams and driving regulatory strategy across multiple markets to join Parexel's highly-respected Regulatory Consulting Team and provide oversight to a vaccine portfolio for a large, dedicated enterprise client partnership.

In this role you will:

Ensure the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP) to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal client process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data. Position may have direct reports.

Responsibilities and Accountabilities

Accountable to Global Regulatory Lead (if not the GRL) and/or Global Regulatory TA Head for development of appropriate 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 to VP level and including representing the client with regulatory agencies as appropriate. Works with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the IAP and the Medicine Profile. Once prioritized by the MDT, work closely with the global commercial team and local regulatory teams in prioritized countries to secure the best possible labelling commensurate with available data and in line with the GDS. In performing the role, the job holder will be responsible for: To proactively develop a regulatory strategy focused on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit advancement of a given program. Ensure implementation of the regulatory strategy(s) in support of the project priorities. Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset. Lead regulatory interactions and the regulatory review processes Ensure effective interaction with local regulatory counterparts in priority markets and global commercial teams Ensure compliance with regulatory requirements at all stages of product life Advocate persuasively to senior leaders in the client’s leadership team and in Health Authorities Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input). If GRL, act as single point of accountability on the EDT/MDT, lead the Regulatory Matrix Team, and deliver the required Regulatory Work Package(s) associated with the IAP. Capable of providing critical regulatory assessment as part of due diligence/business development activities Leadership Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Supports team members to appreciate how their ideas can be combined in order to create value for the whole group. Ability to manage cultural diversity and be effective in leading global teams QualificationsAbility to lead change and communicate difficult messages. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Ensures implementation of longer-term plans or delivery of large scale projects Proven ability to build strong personal network and to use them to secure appropriate support and outcome for a project. Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Adds value through quantitative goal setting and provision of feedback to raise collective performance Business Skills Delivers all communication with clarity, impact and passion, tailored to the audience. Commands attention and interest through the use of a range of communication techniques and styles. Makes complex ideas simple. Is able to effectively interact across all levels and areas within the company. Good listening and comprehension skills; ability to adapt personal style to a given audience; takes ownership and is productive in addressing potential problems before they become an issue Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations. Capable of synthesizing complex information globally to ensure appropriate assessment of the “big picture” for a project 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. Strong overall business acumen. Understands the needs of other functions. Understands the competitive landscape in the commercial and pre-commercial space. Ability to influence and manage conflict in a consensus building manner showing sensitivity to building productive business relationships; demonstrates excellent ability to have conversations in which there may be varying and different opinions or approaches/options. Technical Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views. Strong overall development and clinical acumen. Good understanding of the diseases being developed. Compliance Clear understanding of the importance of following all applicable laws and regulations and fulfilling both the client and Parexel’s expectations and values. Experience, Skills and Specialized Knowledge Required Bachelor 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. Extensive knowledge of relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area. Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally. Ideally, proven experience of leading regulatory activities outside local region. Ideally, has established an external network into other pharmaceutical companies and recognized internally and externally as an expert broadly, or in specific areas, of regulatory affairs. 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.