IQVIA

Regulatory Affairs Director

IQVIA • $128K — $358K *
Parsippany, NJ 07054In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
3 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Lifesciences or related field required
  • Minimum 10 years of relevant experience, including 8 years in regulatory roles
  • Considered a leading expert by peers with extensive knowledge across multiple areas
  • Proficient in regulatory and/or technical writing
  • Advanced negotiation and issue resolution skills
  • Exemplifies calm and diplomatic communication under pressure
  • Strong computer skills, especially in Microsoft Office applications
  • Acts as a mentor to junior team members with a positive demeanor

Responsibilities

  • Direct and manage large, complex regulatory projects with budget and time constraints
  • Conduct risk analysis and develop contingency plans
  • Ensure regulatory colleagues have adequate tools and training for tasks
  • Provide strategic consultancy on various regulatory projects internally and externally
  • Ensure compliance with regulatory processes and prepare for audits
  • Effectively manage meetings and expectations with regulatory agencies
  • Lead bid defense strategy and may represent global regulatory initiatives

Benefits

  • Health and welfare benefits available
  • Potential for performance-based incentives and bonuses
  • Opportunities for professional development and continuing education
  • Flexible work arrangements may be considered
Full Job Description

Job Overview
Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget.

Essential Functions
• May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations
• Undertakes risk analysis, management and contingency plans
• Must ensure that regulatory colleagues on the project have the tools and training needed to undertake the various tasks
• Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results
• Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans
• Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA
• May take leadership role in bid defense strategy and planning
• May act as global regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative
• May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience
• Responsible for making major improvements to processes and systems across functions or large departments
• Problems faced are highly complex and require solutions drawn from best practices and expertise, as well as from extensive analysis into the root cause

Qualifications
• Bachelor's Degree Lifescience or related discipline Required
• At least 10 years relevant experience including 8 years regulatory experience
• Requires extensive knowledge of multiple job areas obtained through advanced education and experience; Viewed as a leading expert within the field by peers
• Extensive experience in regulatory and/or technical writing
• Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach
• Remains calm, assertive and diplomatic in challenging interactions with customers
• Strong software and computer skills, including Microsoft Office  applications
• Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues
• Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
• Ability to exercise independent judgement taking calculated risks when making decisions
•  Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

Keep Up to Date

Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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