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Project Manager– Regulatory Affairs

Clinchoice
ClinChoice
8-10 years
Not Disclosed
10 Jan. 22, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Project Manager – Regulatory Affairs

Location: Europe (Travel to Armenia as needed)
Department: Regulatory Affairs
Employment Type: Full-Time

Role Overview:
We are seeking an experienced Project Manager – Regulatory Affairs to oversee and coordinate regulatory projects, ensuring timely submissions and compliance across global operations. This role requires a proactive, self-driven professional with strong communication skills and experience in managing cross-functional regulatory teams.

Key Responsibilities:

  • Plan, track, and manage long-term regulatory projects and submission timelines.

  • Maintain accurate project documentation, including project plans, status reports, and timelines.

  • Coordinate cross-functional team meetings and facilitate effective communication to meet project milestones.

  • Act as a liaison with clients, understanding their needs and proactively addressing concerns.

  • Monitor regulatory updates and assess their impact on ongoing projects.

  • Support the development and improvement of regulatory project management processes and tools.

  • Track project deliverables and resource utilization to provide direction and support to project teams.

  • Identify, escalate, and resolve project issues promptly to ensure efficiency.

  • Provide independent advice on project management based on prior experience and lessons learned.

  • Contribute to RFI/RFP preparation, defense bids, and guide the sales and business development teams.

Skills and Qualifications:

  • 8–10 years of experience in regulatory operations project management.

  • Strong English communication skills, both written and verbal.

  • Self-driven, adaptable, and able to work independently.

  • Willingness to travel for extended periods, specifically to Armenia.

  • Strong organizational, problem-solving, and cross-functional coordination skills.

Why Join:
This role offers the opportunity to drive global regulatory projects, collaborate with multi-disciplinary teams, and contribute to the successful registration and compliance of products across international markets.

Equal Opportunity Statement:
We are an equal opportunity employer committed to diversity, inclusion, and fair employment practices. Qualified applicants will be considered regardless of race, gender, religion, sexual orientation, disability, or veteran status.