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Senior Regulatory and Start Up Specialist (Mexico)

18 hours, 6 minutes ago
Mexico
Full-time
Senior
Compliance Manager
Operations
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 132

Description

  • Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications within required timelines and local regulatory requirements.
  • Interact with Competent Authorities and Ethics Committees and respond to submission questions or requests.
  • Track and maintain project plans, trackers, and regulatory intelligence tools while keeping leadership updated.
  • Support study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Prepare, review, and manage essential documents required for site activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Coordinate translations for documents required for submission.
  • Partner with site CRAs and cross-functional teams to align communication and support country start-up deliverables.
  • Support budget and contract negotiations and investigator contract execution when required.
  • Act as a subject matter expert and trainer for internal team members on site start-up processes and local regulations.
  • Maintain audit/inspection readiness and file documents in the TMF according to study plans.
  • Support feasibility, pre-study site visits, client updates, and proposal-related activities as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific/healthcare field, or RN, or an equivalent combination of education, training, and experience.
  • 3.5+ years of experience as a regulatory or start-up specialist in a CRO or pharmaceutical/biotech environment, or equivalent relevant experience.
  • Professional-level English proficiency, both written and verbal.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Ability to prioritize workload and meet deadlines.
  • Relevant country-specific regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions, preferred.
  • Experience using milestone tracking tools or systems, preferred.
  • Ability to assist junior start-up specialists in problem solving, preferred.
  • Advanced degree in medical or life sciences, such as MD, PhD, or PharmD, RAC certification, or a Master’s in Regulatory Science, preferred.
  • Knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
  • Ability to work independently in a fast-paced environment with strong attention to detail and accuracy.
  • Excellent computer, presentation, interpersonal, and communication skills.
  • Occasional travel may be required.

Benefits

  • Remote work arrangement indicated by the #LI-REMOTE posting.
  • Equal opportunity employer status with nondiscrimination in employment decisions.
  • Reasonable accommodation support for candidates with disabilities during the application process.
  • Privacy policy and CA privacy notice for applicant data protection.

Interested in this position?

Apply directly on the company website

Apply Now

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