Senior Regulatory Affairs Specialist with Experience in Clinical Trials

hace 3 días


Ciudad de México, Ciudad de México 520 ICR Mexico - MEX A tiempo completo
Job Title: Senior Regulatory Affairs Specialist with Experience in Clinical Trials

Job Summary:

We are seeking a Senior Regulatory Affairs Specialist to join our team at 520 ICR Mexico - MEX. As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.

Key Responsibilities:

* Lead the preparation, submission, and maintenance of regulatory documents for clinical trials.
* Provide expertise and guidance on regulatory requirements and standards to internal teams.
* Interface with regulatory agencies to address inquiries, submissions, and approvals.
* Monitor changes in regulations and guidelines to ensure compliance and mitigate risks.
* Collaborate cross-functionally to support regulatory aspects of clinical trial planning and execution.
* Manage activities associated with obtaining initial, amendment, and other central authority approvals.
* Ensure that IP labels are in adherence to country requirements and submitted where applicable.
* Provide consultancy to the client on any country-specific issues.
* Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs, and BDMs.
* Adapt Informed Consent Form according to local regulations.
* Provide mentoring and training to other entry-level positions if needed.

Requirements:

* Bachelor's degree in a scientific or related field; advanced degree preferred.
* Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotech industry, with experience in Clinical Trials.
* Strong knowledge of global regulatory requirements and guidelines for clinical trials.
* Proven ability to manage regulatory submissions and interactions with regulatory agencies.
* Excellent communication, attention to detail, and problem-solving skills.
* Advanced English for Reading / Writing / Speaking.
* Desirable: e-systems knowledge on CTMS, PhlexEview, PSO, BOX.

What We Offer:

* Competitive salary and benefits package.
* Opportunities for professional growth and development.
* Collaborative and dynamic work environment.
* Recognition and rewards for outstanding performance.

How to Apply:

If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application, including your resume and cover letter, to [insert contact information].

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