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Manager Regulatory Affairs

8+ years
Not Disclosed
10 Dec. 9, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Regulatory Affairs Manager

Location: Flexible
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office


Position Summary

As a Regulatory Affairs Manager, you will lead a team of regulatory professionals, providing strategic intelligence and expertise for product development from preclinical phases through registration and lifecycle management. You will be a key advisor on regulatory strategies, ensuring compliance, driving innovation, and maintaining high ethical and regulatory standards.


Key Responsibilities

Team Leadership

  • Oversee and manage a team, including hiring, onboarding, performance evaluation, goal setting, and professional development.

  • Provide technical and behavioral coaching and mentoring to team members.

  • Approve staff time records, expense reports, leave requests, and overtime.

  • Promote adherence to ethical and regulatory standards within the department.

Regulatory Expertise and Strategic Guidance

  • Act as a subject matter expert, providing strategic regulatory intelligence and technical guidance to internal and external stakeholders.

  • Develop and manage regulatory strategies to support client projects, including preclinical, clinical, and product optimization phases.

  • Ensure high-quality regulatory documentation and submissions, including reviewing and finalizing deliverables.

Project Management and Business Development

  • Identify out-of-scope activities and collaborate with relevant departments to address contract modifications.

  • Lead or participate in project meetings to ensure alignment on objectives and deliverables.

  • Collaborate with business development teams to secure new opportunities, including preparing proposals, budgets, and presentations for clients.

  • Oversee budgeting, forecasting, and project resource allocation.

Compliance and Innovation

  • Stay updated on the latest legislation, regulatory guidelines, and organizational policies to ensure compliance.

  • Drive process improvements and innovation within the department.


Qualifications

Education and Experience

  • Bachelor’s degree or equivalent in a related field.

  • At least 8 years of experience in regulatory affairs or a related field.

  • Minimum of 2 years of leadership experience managing teams.

Skills and Knowledge

  • Strong communication and negotiation skills in English (and local language, where applicable).

  • In-depth knowledge of global, regional, and national regulatory requirements for clinical trial authorization, licensing, and lifecycle management.

  • Expertise in regulatory specialty areas such as preclinical, clinical, CMC, or publishing.

  • Solid understanding of ICH guidelines and other global regulatory standards.

  • Proficiency in project budgeting, forecasting, and data analysis with attention to detail.

  • Effective leadership skills to mentor staff, delegate tasks, and manage priorities.

  • Advanced computer skills, including MS Word, MS Excel, and Adobe Acrobat.


Why Join Us?

By joining our team, you will have the opportunity to shape the future of regulatory affairs in a dynamic and collaborative environment. Leverage your expertise to lead innovative projects, contribute to groundbreaking developments, and foster growth in a supportive, compliance-driven workplace.

If you’re a motivated professional eager to make an impact in regulatory affairs, apply today!