Hub Labeling Senior Associate

Bogotá - Colombia

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Organizational Relationship(s) including to whom the position reports (JD Job Title):

This position reports to the locally based Regional Labeling Head International Labeling Team Lead or to a Senior Manager in International Labeling and Artwork.

Position Purpose

The Hub Labeling Senior Associate level is responsible for executing the content management of non-complex local product documents (LPDs) Local Label Documents (LLDs) and Patient Leaflets for nationally registered products for their assigned products across multiple countries/regions. The Hub Labeling Senior associatealso provides support to the rest of the ILA organization

Primary Responsibilities

Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
Utilize regulatory knowledge to produce noncomplex LPDs LLDs and Patient Leaflets where there are unambiguous relationships to source documents and clear local regulatory principles to follow requesting advice or input from other functions when appropriate.
Production of other labeling-related documentation for submission to HAs such as track change versions annotated labels comparison tables and annotated supportive documentation.
Provides QC support to other labeling colleagues.
Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
Meets defined targets on productivity quality and compliance as set by and overseen by management

Technical Skill Requirements

Strong knowledge/understanding of the principles and concepts of labeling.
Strong knowledge of key regulatory and labeling principles and local regulations

Proficient in use of systems consistent with business expectations and understands importance of systems in maintaining high compliance figures

Fluency in English and Spanish languages
Clear and effective written and verbal communications

Understanding of the importance of Standard Operating Procedures (SOPs) systems and processes in underpinning quality and compliance of deliverables

Qualifications (i.e. preferred education experience attributes)

Life sciences pharmacy graduate or equivalent (desirable); or equivalent relevant professional experience.
Hands on registration experience associated with development maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on LPDs
Ability to successfully understand regulatory implications of product strategy with regard to the product label assessment and practical management of associated impacts is preferable
Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation both in the pre-approval and post approval (maintenance) stages is preferable
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important
Demonstrated project management attention to detail and problem solving skills required.
Proven technical aptitude and ability to quickly learn new software regulations and standards.

Work Location Assignment:Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin or disability.

Regulatory Affairs

Required Experience:

Senior IC

Organizational Relationship(s) including to whom the position reports (JD Job Title):This position reports to the locally based Regional Labeling Head International Labeling Team Lead or to a Senior Manager in International Labeling and Artwork.Position PurposeThe Hub Labeling Senior Associate level...

Organizational Relationship(s) including to whom the position reports (JD Job Title):

This position reports to the locally based Regional Labeling Head International Labeling Team Lead or to a Senior Manager in International Labeling and Artwork.

Position Purpose

Primary Responsibilities

Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
Utilize regulatory knowledge to produce noncomplex LPDs LLDs and Patient Leaflets where there are unambiguous relationships to source documents and clear local regulatory principles to follow requesting advice or input from other functions when appropriate.
Production of other labeling-related documentation for submission to HAs such as track change versions annotated labels comparison tables and annotated supportive documentation.
Provides QC support to other labeling colleagues.
Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
Meets defined targets on productivity quality and compliance as set by and overseen by management

Technical Skill Requirements

Strong knowledge/understanding of the principles and concepts of labeling.
Strong knowledge of key regulatory and labeling principles and local regulations

Proficient in use of systems consistent with business expectations and understands importance of systems in maintaining high compliance figures

Fluency in English and Spanish languages
Clear and effective written and verbal communications

Understanding of the importance of Standard Operating Procedures (SOPs) systems and processes in underpinning quality and compliance of deliverables

Qualifications (i.e. preferred education experience attributes)

Life sciences pharmacy graduate or equivalent (desirable); or equivalent relevant professional experience.
Hands on registration experience associated with development maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on LPDs
Ability to successfully understand regulatory implications of product strategy with regard to the product label assessment and practical management of associated impacts is preferable
Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation both in the pre-approval and post approval (maintenance) stages is preferable
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important
Demonstrated project management attention to detail and problem solving skills required.
Proven technical aptitude and ability to quickly learn new software regulations and standards.

Work Location Assignment:Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility

Regulatory Affairs

Required Experience:

Senior IC

Key Skills

Business Development
Organizational Management
GAAP
Accounting
Analysis Skills
Meeting Facilitation
Microsoft Powerpoint
Investment Banking
Microsoft Excel
Private equity
Financial Modeling
Writing Skills

Apply Now

About Company

Pfizer

Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click