Job Title: Regulatory Consultant (Clinical Trials)
Location: Remote
Department: Parexel Consulting
About Parexel Consulting:
As part of Parexel Consulting, you will leverage your scientific, technical, and regulatory expertise to help biopharmaceutical and medical device companies navigate the complex and ever-evolving regulatory landscape. You will play a key role in developing and implementing regulatory strategies that accelerate the time-to-market for their products while ensuring compliance with regulatory requirements.
We value collaboration, innovation, and continuous learning. As a member of our consulting team, you will be exposed to various product types, therapeutic areas, and challenging assignments, while benefiting from mentorship by experienced professionals. Enjoy the flexibility of remote work, while being part of a dynamic and supportive team environment.
Success Profile:
To thrive at Parexel Consulting, you should possess the following traits:
Communicator: Strong verbal and written communication skills to interact effectively with clients and teams.
Detail-oriented: A keen eye for accuracy and thoroughness.
Problem-solver: Ability to identify challenges and develop solutions.
Relationship-builder: Build and maintain strong professional relationships.
Results-driven: Focused on delivering successful outcomes.
Strategic: Able to think critically and plan for long-term success.
Key Responsibilities:
Clinical Trial Regulatory Submissions:
Over 15 years of relevant experience in clinical trial regulatory submissions.
Lead and manage regulatory submissions for global clinical trials, particularly with experience in the European market.
Proficiency in managing CTIS database and submitting EU CTR and CDSCO submissions is desirable.
Regulatory Leadership:
Serve as the Regulatory Lead for global clinical trials, ensuring timely and compliant submissions.
Manage the profitability of multiple projects by preparing project plans and budgets, actively addressing any revenue recognition issues.
Proactively resolve issues and conflicts that arise during project execution.
Project Management & Efficiency:
Work within a team or independently, depending on project needs, to manage workload effectively and meet project goals.
Monitor and improve project efficiency, identifying opportunities to enhance team performance and deliver results.
Manage project budgets, ensuring alignment with financial expectations.
Mentorship and Staff Development:
Provide guidance to junior team members and mentor staff to ensure their professional growth and development.
Lead performance management activities for direct reports, including performance reviews, salary actions, and rewards.
Develop staff development plans and coordinate with strategic resourcing to ensure proper staff utilization.
Leadership and Team Collaboration:
Lead, coach, and provide feedback to project teams, ensuring high-quality service delivery.
Communicate the company’s vision, values, and strategic goals to ensure alignment within the team.
Regularly communicate with staff to ensure smooth information flow, addressing business updates, concerns, and team interests.
Consulting Services:
Provide a wide range of technical and business consulting services, especially where policy or regulatory precedents are well-established.
Use your expertise to assess project issues, develop strategies, and ensure client and project goals are met.
Self-Development and Industry Knowledge:
Stay current with industry trends and regulatory changes, maintaining memberships in relevant industry associations.
Proactively pursue opportunities for skill expansion, ensuring that the team has access to the latest developments in regulatory practices.
Quality and Strategy Development:
Ensure all project work meets client expectations and is completed with high quality.
Review colleagues' work for accuracy and content, ensuring compliance with regulatory standards and Parexel’s quality expectations.
Develop strategies to enhance productivity, quality, and overall project success.
Skills and Experience:
Extensive experience in regulatory submissions for clinical trials, particularly with exposure to the European market.
Proficiency in managing CTIS database and submissions to EU CTR and CDSCO is a plus.
Strong project management skills, with the ability to manage multiple projects and meet financial and timeline objectives.
Proven experience in mentoring and managing teams, with a focus on performance development and staff support.
Excellent communication and relationship-building skills, with the ability to influence and resolve conflicts effectively.
A strategic thinker with a strong ability to develop and implement actionable regulatory strategies.
Education and Qualifications:
Required: Degree in a relevant discipline (e.g., Regulatory Affairs, Life Sciences, Pharmacy), or equivalent work experience in regulatory consulting.
Why Parexel Consulting?
Parexel Consulting offers a collaborative, innovative, and growth-oriented work environment. With the flexibility to work remotely and the opportunity to engage in high-impact, cross-functional projects, you will be able to develop your career while making a significant contribution to the success of our clients and their products.
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