This job has expired and is no longer accepting applications.
Similar live jobs
Remote opportunity at
pfm medical, inc.Senior Regulatory and Start Up Specialist (Mexico)
pfm medical, inc. is looking for a remote Senior Regulatory and Start Up Specialist (Mexico) to join its team on a full-time basis. This role is…
Career Tools
About this role
Senior Regulatory and Start Up Specialist (Mexico) at pfm medical, inc. is a full-time role. Work arrangement: Remote. Location: Applicants in United States only. No salary is shown in this listing. It was posted on Oct 27, 2026. This listing is paused and not taking applications at the moment.
Job Description
pfm medical, inc. is looking for a remote Senior Regulatory and Start Up Specialist (Mexico) to join its team on a full-time basis. This role is ideal for an experienced clinical research professional who specializes in regulatory affairs and site initiation across Mexico. The person in this position will manage critical regulatory submissions, coordinate essential trial documents, and facilitate communication between study sites, ethics committees, and internal project teams.
As a key player in the organization's expansion efforts, the Senior Regulatory and Start Up Specialist will oversee timely site activation readiness, handle clinical trial applications, and navigate local regulatory frameworks. Responsibilities involve adapting informed consent forms, handling translation coordination, maintaining project tracking tools, and collaborating with site contract management groups on budgets and investigator agreements. Furthermore, the professional may act as a subject matter expert, train junior staff, and assist with feasibility assessments or pre-study site visits.
Responsibilities
- Prepare and submit clinical trial application forms and dossiers to Competent Authorities, Ethics Committees, and local bodies
- Review, adapt, and coordinate translations for Patient Information Sheets and Informed Consent Forms
- Collect, review, and manage essential documents required for site activation and investigational medicinal product release
- Maintain communication with clinical operations, feasibility, project management, and regulatory teams regarding project status
- Update project plans, trackers, and regulatory intelligence tools while keeping leadership informed
- Support or participate in study budget negotiations and investigator contract execution under guidance
- Maintain audit and inspection readiness while filing documents according to trial master file plans
- Mentor junior staff on local study start-up regulations, submission processes, and internal procedures
- Interact with clients to give activation readiness status updates and support proposal activities
Requirements
- At least 3.5 years of experience as a regulatory or site start-up specialist within a CRO, pharmaceutical industry, or biotech industry
- Professional proficiency in both written and spoken English, alongside fluency in the local language of the employment country
- Experience utilizing electronic spreadsheets, word processing tools, electronic mail, and computerized information systems
- Ability to prioritize workloads to meet strict deadlines in a fast-paced environment
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor degree in a life sciences, scientific, or healthcare discipline, or registration as a nurse or equivalent combination of training and experience
- Advanced degree in medical or life sciences such as an MD, PhD, or PharmD
- Regulatory Affairs Certification (RAC)
- Master degree in Regulatory Science
- Prior experience handling feasibility, contract negotiations, and ethics committee submissions for the specific country
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the source posting indicates that the role is remote.
What is the employment type?
The position is full-time.
What education or background is required?
Candidates must have a bachelor degree in life sciences or a related scientific or healthcare field, or be a Registered Nurse, paired with at least 3.5 years of relevant regulatory or site start-up experience in a CRO, pharmaceutical, or biotech setting.
What salary does the position offer?
The job posting does not specify a salary.
Sample Interview Questions
AI-generated questions tailored to this specific role — a preview of the full practice set.
Explore more jobs like this
What to do next
This listing is no longer open, so the quickest next step is one of the live roles above. Save the ones that fit, and check the employer's other openings on its company page. To hear about new matches as they are posted, set up a job alert from your candidate account.