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Precision Medicine GroupSenior Regulatory and Start Up Specialist (Mexico)
Precision Medicine Group is expanding operations across Latin America and is seeking a Senior Regulatory and Start Up Specialist based in Mexico. This full-time position focuses…
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About This Role
Precision Medicine Group is expanding operations across Latin America and is seeking a Senior Regulatory and Start Up Specialist based in Mexico. This full-time position focuses on handling clinical trial submissions, regulatory compliance, and site start-up activities. The organization provides services to the life sciences industry and requires an experienced professional to manage complex start-up processes and mentor newer team members. This role suits individuals with a strong background in…
Job Description
Precision Medicine Group is expanding operations across Latin America and is seeking a Senior Regulatory and Start Up Specialist based in Mexico. This full-time position focuses on handling clinical trial submissions, regulatory compliance, and site start-up activities. The organization provides services to the life sciences industry and requires an experienced professional to manage complex start-up processes and mentor newer team members.
This role suits individuals with a strong background in clinical trial regulations who can work independently in a fast-paced setting. Responsibilities encompass preparing clinical trial applications, interacting with competent authorities and ethics committees, gathering essential documents, and negotiating budgets and contracts. The selected candidate will also act as a subject matter expert, maintain regulatory intelligence tools, and ensure audit readiness while collaborating with internal clinical teams and external clients.
Responsibilities
- Manage initial and subsequent clinical trial submissions to Competent Authorities and Ethics Committees
- Review, adapt, and translate Informed Consent Forms and patient information sheets
- Collect, review, and manage essential documents required for site activation and investigational medicinal product release
- Support site contract management in budget negotiations and investigator contract execution
- Maintain project plans, tracking systems, and regulatory intelligence tools
- Communicate regularly with project managers, clinical operations, and study leads regarding activation status
- Serve as a subject matter expert and mentor for less-experienced staff on local start-up procedures
- Participate in pre-study site visits and investigator outreach for feasibility assessments
Requirements
- Minimum of 3.5 years of experience as a regulatory or start-up specialist within a CRO, pharmaceutical company, or biotech organization
- Professional proficiency in English as well as the local language
- Experience using computerized information systems, electronic spreadsheets, word processing, and email
- Familiarity with Good Clinical Practice and ICH guidelines
Qualifications
- Bachelor degree in life sciences, a scientific or healthcare discipline, Registered Nurse, or equivalent education and experience
- Advanced degree in medical or life sciences such as an MD, PhD, or PharmD
- Regulatory Affairs Certification
- Master degree in Regulatory Science
- Experience utilizing milestone tracking tools and handling country-specific feasibility, contract negotiations, and ethics committee submissions
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the employment type for this role?
This position is full-time.
What is the salary offered for this position?
The source posting does not specify a salary.
What education is required to apply?
A bachelor degree in life sciences or a related scientific/healthcare field, or a Registered Nurse qualification is required, though an advanced degree or RAC certification is preferred.
Sample Interview Questions
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