RemoteLeaf Logo
Log in Sign up

Senior Regulatory and Start Up Specialist (Brazil)

1 month, 1 week ago
Brazil
Senior
Compliance Manager
Operations
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 63

Description

  • Prepare and manage clinical trial submissions, amendments, and notifications to Competent Authorities and Ethics Committees.
  • Review and adapt informed consent forms and patient information sheets for country/site use.
  • Collect, review, and maintain essential documents required for site activation and IMP release.
  • Support IRB/EC submissions and respond to questions or requests from regulatory authorities and ethics committees.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep leadership updated on status and risks.
  • Coordinate with site CRAs, Clinical Operations, Project Management, Regulatory, and Site Contracts teams to align deliverables.
  • Support budget and investigator contract negotiations with the Site Contract Management group as needed.
  • Act as a subject matter expert on country start-up activities, regulations, and critical path timelines.
  • Train and mentor less-experienced staff on submissions, procedures, and local start-up requirements.
  • Maintain audit and inspection readiness and file documents in the TMF according to study plans.

Requirements

  • Bachelor’s degree in life sciences or a related scientific/healthcare field, or Registered Nurse, or equivalent education, training, and experience.
  • 3.5+ years of experience as a Regulatory or site start-up specialist in CRO, pharmaceutical, or biotech environments.
  • Professional-level English communication skills, both written and verbal.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the role 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.
  • Knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
  • Preferred: country-specific regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions.
  • Preferred: experience using milestone tracking tools/systems, plus advanced degree (MD, PhD, PharmD), RAC certification, or Master’s in Regulatory Science.

Benefits

  • Remote work is indicated by the posting (#LI-REMOTE).
  • Opportunity to join as the first Senior Regulatory and Start Up Specialist in Brazil.
  • Occasional travel may be required.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Pathward

EFT Specialist I

Pathward 251-1K Diversified Financial Services

Pathward is hiring a banking operations professional to process funds movement and support deposit and payment services while meeting internal policies and regulatory requirements.

Anywhere Full-time Entry Level Operations Specialist
$36k-$58k
8 hours, 46 minutes ago
CoinGecko

Operations Associate

CoinGecko 51-250 IT Services

CoinGecko is hiring an Operations professional to support cryptocurrency data-platform customers, assess listings, coordinate issue resolution, and improve operational processes across its global Web3 business.

Philippines Contract Mid Level Operations Specialist
Bitcoin Blockchain CRM Ethereum
9 hours, 1 minute ago
Binance

Binance Accelerator Program - Web3 Operations (for current university students)

Binance 5K-10K Capital Markets

Binance is hiring an early-career team member for its Wallet team to support community insights, project coordination, and business solutions for its decentralized Web3 wallet ecosystem.

Middle East Asia United Arab Emirates Taiwan Contract Entry Level Operations Specialist
Blockchain
9 hours, 1 minute ago
BeyondTrust

Government Compliance Technical Specialist

BeyondTrust 1K-5K Professional Services

BeyondTrust is hiring a Government Compliance Technical Specialist to execute and modernize its FedRAMP, TX-RAMP, IRAP, and related public-sector compliance programs within the Trust & Assurance team.

United States Canada Full-time Senior Compliance Manager
Cybersecurity
9 hours, 16 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers