Director / Associate Director _ Regulatory Strategy (Remote)

IQVIA is changing an entire industry through inspired innovation. Our People make the difference. We believe that great ideas can come from anywhere. Great products come from great ideas. And great ideas come from great people. We look for the very best people and then give them meaningful work to do. Join IQVIA and help us make the world a better place.

PURPOSE

• Provide regulatory strategy leadership and consultancy to support the development of optimum strategies for drug development, product lifecycle management and portfolio management to meet pharmaceutical and biotechnology client goals
• Delivery of regulatory operations activities, including creation and review of regulatory documentation and materials, interaction with regulatory agencies, management of client regulatory affairs
• Support the development of SDD’s regulatory strategy business, collaborating across and beyond SDD and IQVIA to create industry-leading offerings
• Contribute to thought leadership in the regulation of pharmaceutical product development

RESPONSIBILITIES

• Support to the evaluation and development of regulatory strategies for pharmaceutical products (drugs, biologics, advanced therapies), across all phases of development, with emphasis on US FDA and EU EMA, ensuring application of appropriate guidance, precedents and regulatory insights and know-how
• Strategic leadership / support of engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including attendance and contribution to meetings and other interactions
• Strategic leadership / support of the development of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), special designations (orphan drugs, pediatrics plans, “fast-track”, “break-through” etc…)
• Creation and or review of documents to support regulatory interactions and submissions including, but not limited to, protocol synopses; pre-IND / SA briefing packages; clinical trial authorizations (INDs, CTAs); orphan drug and other special designations; marketing authorization applications (NDAs, BLAs, NDSs, MAAs), device authorizations (IDEs, 510Ks, PMAs).
• Lead / support assessments of risk and probability of regulatory success and development of mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritization exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.
• Support the innovative development of compounds to maximize technical, regulatory, and commercial success, through contribution of regulatory insights and expertise to the development of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as appropriate
• Support customer engagements and interactions on regulatory strategy topics, creating and developing “trusted advisor” role
• Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical, and scientific integrity and conduct.
• Drive the development of internal processes, procedures, and templates to optimize SDD ways of working
• Support development of business strategy for SDD, to define and develop regulatory strategy solutions, to drive increase in market share and profitability, in collaboration with colleagues in SDD and across the wider IQVIA
• Provide regulatory strategy expertise to support strategic business activities and investment opportunities.

• Serve as a key resource and participate in strategic business development activities including presentations to prospective clients, professional meetings, or other business development activities for SDD and IQVIA

• Provide internal and external educational services in support of all branches of IQVIA business, as required

• Support development of thought leadership including attending key scientific meetings/conferences, authoring of white papers, blogs, and other publications, and maintain knowledge of current regulatory environment; As appropriate, represent IQVIA or clients at external meetings.
• Develop and maintain ongoing relationships with pharmaceutical and biotechnology companies, regulatory agencies, key opinion leaders; identify new business opportunities.
• Compliance with all business office requirements for tracking of time and effort.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Deep, current knowledge of the regulation of the clinical development of pharmaceutical products, across a broad range of therapeutic areas, treatment modalities and development stages. Knowledge of Chemistry, Manufacturing and Controls (CMC) regulation would be an advantage.
• Understanding of the requirements of successful consultancy. Capable of working independently (self-starter) or within, and contributing to, a team. Ability to work on multiple projects in parallel.
• Proven ability to create a wide variety of high-quality regulatory documentation and successful interaction with regulatory authorities
• Proven ability to support the definition and delivery of regulatory strategy to a broad range of clients and other senior stakeholders
• Ability to communicate information at all levels within our Customers’ and Partners’ organizations and within IQVIA by expressing ideas in an effective and highly influential manner. 
• Ability to effectively manage projects, to establish and meet priorities, deadlines, strategic department goals and objectives
• Ability to lead and contribute to cross-functional teams, including steering committees and advisory boards
• Ability to thrive within a rapidly changing environment
• Strong interpersonal and collaborative skills
• Analytical, consultative, and solution-oriented
• Creative, enthusiastic, dynamic, and positive
• Financial understanding and acumen

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in relevant scientific discipline. Doctorate would be advantageous (MD, PhD, DDS, PharmD, DrPH, or equivalent)
• A thorough knowledge of clinical regulatory strategy gained from at least 5-7 years’ experience, within a regulatory agency, pharma or biotech company, consultancy or CRO.
• Fluency in verbal and written English. Ability in Mandarin Chinese would be advantageous

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.