Regulatory Affairs Specialist

Primary Job Function/Mission

Put in place the strategic vision through the development of regulatory dossiers as subject matter expert (SME) assuring the correct and clear information across the process.

Influencing the regulatory environment with a clear purpose to achieve that includes regulatory timelines evaluation and approval avoid deficiency letters increase understanding of product information.

Assure internal regulatory processes to be accurate and on time for audit processes.

Main Resposibilities:

• Preparation of stateoftheart regulatory dossiers according to product regulatory strategy previously aligned.
• Tend to look always for a first pass approval from the health authorities. In case any inquire assure a timely and accurate response as well as look for learning avoiding same inquiries in future regulatory processes.
• Responsible for safety information update contained in the local labeling of products marketed in North Region according to AbbVie policies and local regulations (CCDS Management).
• Update the local and global platforms of regulatory affairs in accordance with the submissions and prepared dossiers executed by this position.
• Coordinate and execute the review harmonization and approval (AMS) of labeling associated to commercialized products prior to its implementation in accordance with applicable global and local policies.
• To follow up resolutions and concepts issued by regulatory entities related to regulatory procedures as well as the review of approvals according to the submissions executed by this position.
• Review and approve promotional and nonpromotional material as assigned to this position. Administrate the promotional and nonpromotional materials tool.
• Actively participate in regulatory and other related meetings with key business stake holders providing the necessary regulatory support.
• Provide documentary and technical support to tenders customer service in Cluster North for the specialty care portfolio.

Position Accountability / Scope

• This position must guarantee that all documentation and regulatory process are according to local regulations and AbbVie corporate policies.
• To support the documentary and technical information for tenders customer service in North Region for the portfolio.
• This position must represent to Region North as SME for corporate and local regulatory tools.
• Dossier preparation.

Qualifications :

Bachelors in Pharmacy chemical engineering or related education.

At least two years  of experience in pharmaceutical industry within quality assurance or regulatory activities

Advanced English Level 

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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Work :

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