Regulatory Affairs Specialist

hace 3 meses

Ciudad de México CDMX Fenixfarma Mexico City, Mexico A tiempo completo

Regulatory Affairs Specialist

Job description:
Full time On-Site, 9:00AM to 6:00PM in Polanco CDMX, Mexico

Immediate job

Chemist/ Biologist and also Pharmacist Diploma in order to act as sanitary responsible

Experience in Dossier preparation for Drug products: take care of the preparation of your dossier. Printing, submitting.

Including preparations of all legal documents, translations, label artwork...

Approving and submitting Pharmaceutical dossiers to COFEPRIS.

High communication skills in English & Spanish

Experience in drug product registration at COFEPRIS

Regulatory affairs:
1) Connect between companies/manufacturer and regulatory authorities by ensuring that products are manufactured, tested, and distributed in compliance with appropriate legislation.

3) RA responsible for preparing responses to customer requests for information, reviewing clinical protocols, writing or updating standard operating procedures, work instructions, or policies.

4) Must ensure the organization complies with applicable regulations, developing processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored.

5) RA responsible for checking the patent expiration of date and make sure the registration is permitted. Additionally must approve accuracy of manufacturer product presentation to our local tender requirements.

6) Work on registration of FDF (finished dosage formulation) and also API (Active Pharmaceutical ingredients).

Immediate JOB

Areas of Responsibility

Ensure that the company, products and processes in the area comply with applicable local health regulations.

Lead a team of regulatory specialists, define the strategy, presentation and approval of new products, new indications, line extensions, variations of the marketing authorization document and renewal of the products under your responsibility.

Collaborate with other areas of the company in the interpretation of health regulations, their monitoring, updating and identification of risk factors or opportunities in their implementation.

Effective communication with global and regional teams, along with different local actors to define the pipeline strategy, with solid technical knowledge and business vision.

Adequately represent the company before the health authority in order to ensure the timely review and authorization of the company's requests and procedures.

Strategic and creative thinking: Ability to understand the business model, strategic imperatives, develop innovative ideas or process improvements to incorporate them into the development of strategies and regulatory plans.

Technical and regulatory knowledge: Ability to understand new technologies and establish authorization mechanisms in compliance with regulations, including the design of new regulatory pathways.

Attention to detail with adherence to procedures: Exhaustive review of documentation, effective and precise management of documents, guides, systems and databases.

Influence and Communication: Ability to present technical or complex situations in a simple way that facilitates understanding and adoption by internal or external people. Collaborate in building effective relationships. Ability to negotiate or influence internal and external clients.

Collaboration and teamwork: Demonstrated ability to develop interpersonal and business relationships with all different local, regional and global business areas.

Academic preparation

Minimum: Bachelor's degree in Health Sciences in pharmaceutical area. Desirable: Postgraduate.

Advanced English.

Experience in Regulatory Affairs (3+ years) at an operational level and desirable experience with staff in charge (2-3 years)

Regulatory Assessment / Gap Analysis: Review and verify that file is complete and ready to start the technical evaluation process.

Regulatory Reporting service: Prepare clinical or pre-clinical information of drug product to facilitate communication and analysis to regulatory agencies.

Health Registrations:
Evaluate the technical, scientific, administrative and legal information.

Reduce the risk of having some prevention by the authority, preventing the processes from being extended in time.

Help you find the right classification for your product.

Pharmacovigilance and technovigilance: Risk management plan for New molecule; submit to the regulatory authority. Support the plan and all the corresponding reports that are needed.

Patent Expiration: prove expiration date of patent.

Forecasts: Research market & prepare forecasts for drug products based on IMSS tender reports.

Experience with Google Suite & Microsoft Office.

Good clinical practices

Warehouse

Good distribution practices

Diligent, smart, independent, can work under pressure.

Application Question(s):

- Are you willing to commit to work for a minimum of 6 month?
- Have you ever worked at a pharmaceutical startup company?

**Education**:

- Bachelor's (preferred)

**Experienc

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