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Regulatory Strategist Analyst


Bogota, NJ
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Job Details

**Position Purpose:**

Perform all the activities related to the planning, definition, implementation and monitoring of appropriate regulatory strategies and processes for the L-HSP Dossier Conformance Program to ensure regulatory compliance of the LatAm L-HSP portfolio according to the health regulations in force in the markets and the company policies in line with corporate and business needs.

**Primary responsibilities:**

Apply country's regulatory expertise in communicating documentation to prepare dossiers according to Health Authority (HA) requirements and local legislations, ensuring high quality information and compliance with Pfizer standards.

Identify, assess and remediate potential gaps in conformance between manufacturing documents, the source dossier and marketing dossiers.

Prepare reports required by the RA Director /Manager of products under the scope of HSP Conformance Project.

Support to country regulatory departments in regards to regulatory issues associated with the products under responsibility, providing input to the CRLs in relation to processes and regulatory strategies.

**Technical Skill Requirements:**

+ Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat.

+ Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

+ Functional and technical knowledge and skills to do the job at a high level of accomplishment

+ Proven technical aptitude

+ Quick learner with ability to multi-task

+ Ability to work with accuracy and attention to detail

+ Ability to work with autonomy and/or part of a team in a busy environment

+ Demonstrated ability to work in a highly regulated environment

+ Quality focus

+ Customer orientation

+ Analysis and solution of problems

+ Effective communication

+ English intermediate to advance. Read Portuguese would be one advantage **Qualifications (i.e., preferred education, experience, attributes):** ** Academic Degree: Professional in Pharmaceutical Chemistry** ** Regulatory knowledge and experience (at least 1-2 years)** Demonstrated ability to work in a highly regulated environment Project Management Experience desirableFixed Term - 6 months

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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