Regulatory Affairs Specialist (Temporary)

Job Description

Execute the Regulatory Road Map of the products in the assigned portfolio and at a transversal level as required by the area. Ensure compliance with local regulations to achieve the regulatory objectives for the subsidiary. Provide advisory and support to HQ stakeholders, marketing, logistics, quality, planning divisions, among others, in the projects that are required. Interact with the agency, follow up on regulatory filings and procedures related with the portfolio and projects assigned as required. Also, this role is responsible for leading the evaluation and notification of Promotional and Non-Promotional Materials of the company, as required, to the regulatory agency.

Main functions:

• Be updated on new or changes in laws, regulations, normative, in force or under proposal to keep the company aware and in compliance with the different government regulations.

• Ensure and execute regulatory strategy and compliance for preparation, submission and monitoring of the regulatory procedures such as: New Registrations (OMA), New indications, Renewals, Variations (PAC), and other regulatory procedures in general, etc. for  the assigned Portfolio and at a transversal level as required.

• Evaluate, review, and timely present to the regulatory agency the materials used from Oncology, Pharma, Vaccines, and Access business units in promotional and non-promotional activities as required. Ensuring compliance with current regulations and providing cross-functional support in the impacted processes.

• Support Tenders and Sales (and   other areas that may require it) obtaining the necessary documentation for their processes (eg: Letters, GPM, Certifications, among others)

• Establish good working relationships with both internal and external staff (regulatory agency, associations, regulatory consultants) maintaining a professional image on behalf of the company.

• Execute labeling updates (information to prescribe and insert) of the products within the established due dates. Planning filing and implementation in compliance with what is approved or required by HQ and the regulatory agency.

• Protect the company's information by ensuring that it is not disclosed except when necessary and when it is duly covered with the appropriate confidentiality agreements.

• Execute Regulatory Road Map for portfolio assigned.

• Provide revision to local RA SOPs updates and comply with the established there.

• Maintain updated the certificates of Good Manufacturing Practices of all the corresponding sites and Certificates of Pharmaceutical Products for portfolio assigned.

• Perform trainings as required within the established times.

• Perform champion/SME tasks of the assigned process or internal system.

• Keep updated the different corporate regulatory tracking, repository, or archive tools, etc. within the established times, maintaining KPIs with required standard. 

• Request artworks updates when apply through the corporate system, ensuring right first time within the established times.

• Participation and/or collaborative in trade associations.

Qualifications:

• Bachelor’s degree in Pharmacist / Pharmaceutical sciences required.
• Fluency in English - speaking, writing, reading- highly recommendable.

Experience:

• More than 2 years in pharmaceutical industries in Regulatory affairs positions. Prior experience in the pharmaceutical industry is preferred.
• Prove knowledge in local regulations general and specific for drugs, small molecules, and biologics.
• Ability to communicate effectively, both verbally and in writing, with individuals at all levels of the organization.
• Management internal platforms/programs for regulatory activities.
• Good organizational skills with the ability to effectively manage multiple activities across various projects simultaneously.

Required Skills:

Preferred Skills:

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