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Associate Director, Regulatory Affairs

15+ years
Not Disclosed
10 Sept. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

When our values align, there's no limit to what we can achieve.

At Parexel, we share a common goal: to improve global health. From clinical trials to regulatory consulting and market access, each solution we provide is driven by our deep commitment to our mission.

Every role at Parexel contributes to the development of therapies that ultimately benefit patients. We take our work personally, approach it with empathy, and are dedicated to making a meaningful difference.

Key Responsibilities:

  • Clinical Trial Regulatory Submissions: Over 15 years of relevant experience in managing regulatory submissions for clinical trials.

  • Regulatory Leadership: Experience leading global clinical trial studies, particularly in the European market.

  • Database Expertise: Proficiency in handling the CTIS database, including submissions to the EU CTR and CDSCO is desirable.

  • Project Profitability: Monitor the profitability of multiple projects by collaborating with project leads to prepare plans and manage budgets.

  • Revenue Recognition: Proactively identify and resolve issues related to revenue recognition.

  • Team Collaboration: Work effectively within a team environment or independently based on project requirements.

  • Mentorship: Provide guidance to project team members and serve as a mentor to staff.

  • Issue Resolution: Navigate broad project guidelines to lead the resolution of issues and conflicts.

  • Workload Management: Prioritize your own workload and that of the project team to meet objectives.

  • Efficiency Improvement: Identify and act on opportunities to enhance project efficiency and team performance.

  • Performance Management: Actively manage performance, including HR activities for direct reports (e.g., performance reviews, salary actions).

  • Staff Support: Provide input on staffing needs and assist direct reports in managing their teams.

  • Guidance and Accountability: Support staff in achieving key metrics while holding them accountable for performance.

  • Staff Development: Facilitate development plans and collaborate with strategic resourcing to optimize staff utilization.

  • Skill Expansion: Work with strategic resourcing to offer staff opportunities to broaden their skill sets.

  • Recognition and Reward: Ensure staff are recognized and rewarded appropriately.

  • Leadership and Mentoring: Offer leadership, coaching, and feedback to managers and staff, ensuring quality and accuracy in services.

  • Vision and Values Communication: Promote the organization's vision and values.

  • Effective Communication: Maintain open lines of communication with staff to facilitate effective information flow.

  • Consulting Services: Deliver a full range of technical and business consulting services, especially where policies or precedents are clear.

  • Self-Development: Pursue self-development activities to stay current in the industry (e.g., maintaining membership in relevant associations).

  • Project Efficiency: Continuously seek opportunities to enhance project efficiency and team outcomes.

  • Information Leverage: Utilize insights from past projects to efficiently complete tasks and support business decisions.

  • Quality Work: Produce high-quality work that meets client expectations and review colleagues' work for content and quality.

  • Strategy Development: Analyze project challenges and develop strategies to achieve productivity, quality, and project objectives.

  • Performance Management: Actively oversee performance management for direct reports, including typical HR responsibilities.