Regulatory Affairs Consultant — Sr. PLM Compliance & Licensing

ClinChoice; México; Presencial; MXN 1,272,000 - 1,637,000; Jornada completa

Descripción de la vacante

A global CRO is seeking a Regulatory Affairs Specialist – Consultant for a 12-month contract in Mexico. This role focuses on maintaining compliance through managing certificate requests and drug listing submissions to the FDA. Candidates must have at least 3 years of regulatory experience and proficiency with US Annual Reports. Strong communication and leadership skills, along with familiarity with pharmaceutical environments, are desirable. The position promises a supportive work culture aimed at quality and professional development.

Formación

• 3+ years of regulatory experience required.
• Experience with US Annual Reports is necessary.
• Ability to support international product approvals is essential.

Responsabilidades

• Review and process new certificate requests accurately.
• Compile NDA Annual Reports and drug listings for FDA submissions.
• Manage multiple tasks and deadlines efficiently.

Conocimientos

Regulatory experience

Submitting US Annual Reports

International product approval

Quality focus

Technical aptitude

Leadership skills

Microsoft Office Suite

Effective communication

Accountability

Educación

Bachelor’s degree or equivalent experience

Descripción del empleo

A global CRO is seeking a Regulatory Affairs Specialist – Consultant for a 12-month contract in Mexico. This role focuses on maintaining compliance through managing certificate requests and drug listing submissions to the FDA. Candidates must have at least 3 years of regulatory experience and proficiency with US Annual Reports. Strong communication and leadership skills, along with familiarity with pharmaceutical environments, are desirable. The position promises a supportive work culture aimed at quality and professional development.