Regulatory Affairs Specialist – Consultant

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

Regulatory Affairs Specialist – Consultant

Mexico

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Specialist – Consultant (Sr. Product License Maintenance Manager, (PLM) Compliance Support) for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Job Description

Sr. Product License Maintenance Manager, (PLM) Compliance Support

Responsibilities

• Accountable for reviewing new certificate requests and forwarding to relevant suppliers for processing.
• Responsible for NDA Annual Report compilation and Drug Listing submissions to FDA.
• Manages multiple tasks simultaneously to ensure performance metrics and filing deadlines are achieved according to agreed targets and BOH due dates.
• Liaise with where necessary to collect the information needed to submit the certificate request to the Contractor. If re‑work is identified, track all rework through systems.
• Forward request to the identified Contractor for processing, within the timeframes identified by the relevant project team.
• If required, manage legalization through Consular Services ensuring relevant administration, fees are completed and timelines adhered to.
• Communicate with requestor, Contractor or Consular Service to ensure request is processed, queries are answered and timelines are met.
• Project manage multiple requests simultaneously, ensuring filing deadlines are reached and next action dates are maintained in real time by pulling pending reports from systems.
• Escalate to client and contractor point of contact when timelines may not be reached.
• Maintain client systems and process throughout processing of request to ensure real time reflection of request is visible to all users.
• Seek approval from client’s end lead when certificates require fast tracking.
• Support delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, and NDA Annual Report submission to FDA.
• Continuous improvement of selected processes relating to human health submissions and selected drug and non‑drug specific projects and related activities (e.g., drug listing and establishment registrations).
• Deliver Product License Maintenance Portfolio in a timely and quality manner.

Qualifications

• 3+ years regulatory experience.
• Experience submitting US Annual Reports.
• Demonstrated ability to support international product approval.
• Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines.
• Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.
• Can demonstrate leadership and team skills.
• Advanced Microsoft Office Suite skills.
• Highly efficient communicator.
• Acts decisively and seizes accountability.
• Bachelor’s degree level (desirable or equivalent work experience).
• Familiarity with pharmaceutical organizational structures.