Regulatory Affairs Manager

Manager Regulatory Affairs – Global Labeling Product Leader Location :

Brazil (Remote) Type :

Full Time | 12 Month Fixed Term Contract (FTC) Start Date :

ASAP

About the Company : Our client is a

global healthcare leader

specializing in innovative pharmaceutical and medical products that improve patient outcomes worldwide. With a strong focus on quality, safety, and compliance, the company operates across multiple therapeutic areas and global markets. The successful candidate will join a collaborative Regulatory Affairs organization driving excellence in labeling compliance and product lifecycle management.

Position Summary : The

Manager Global Labeling Product Leader

is responsible for the

development maintenance and quality oversight

of primary and derived product labeling documents across global markets. This position ensures that labeling content is compliant with international regulations and internal quality standards while contributing to global labeling strategy and product lifecycle management. You will act as a key liaison between cross functional teams including Regulatory Affairs Safety Medical and Commercial to deliver consistent compliant and scientifically accurate product information.

Key Responsibilities Lead the

creation revision and maintenance

of primary and derived labeling documents (for example CCDS USPI SmPC) ensuring alignment with regulatory requirements and company strategy. Collaborate cross functionally with

Subject Matter Experts (SMEs)

through

Labeling Working Groups (LWG)

and

Labeling Committees (LC)

to gain consensus on labeling content. Develop labeling text supported by clinical preclinical and safety data considering competitor and market context. Ensure the accuracy clarity and scientific integrity of labeling documents through effective data review and documentation traceability. Support the implementation of

global labeling strategies

including the development of target labeling for new and existing products. Partner with

Global Regulatory Affairs (GRA)

and

Global Labeling Operations (GLO)

to ensure dissemination and alignment of labeling deliverables. Maintain up to date understanding of global labeling regulations (EU US and international) CIOMS guidance and industry best practices. Support audits inspections and

Corrective and Preventive Action (CAPA)

management related to labeling activities. Contribute to

continuous improvement initiatives

to optimize labeling processes and documentation quality. Provide labeling support and guidance to regional and local operating companies ensuring compliance across markets.

Qualifications and Experience

Essential : Bachelor’s degree in

Life Sciences Pharmacy or a related discipline . Minimum

4 years of experience

in the

pharmaceutical or healthcare industry

with at least

3 years in Regulatory Affairs

and product labeling. Proven understanding of

global labeling regulations

(FDA EMA CIOMS) and regulatory documentation standards. Demonstrated ability to interpret clinical and technical data and translate findings into compliant labeling text. Strong skills in

scientific writing

data interpretation

and

document management systems (DMS) . Excellent communication and interpersonal skills with the ability to work in a

matrixed cross functional environment . Proficiency in

Microsoft Word

with working knowledge of

Excel

and

PowerPoint .

Desirable : Advanced degree (MS PhD MD or PharmD) in a life sciences discipline. Experience leading projects or small teams in a global regulatory or labeling capacity. Previous participation in

process improvement

or

compliance initiatives . Experience with

labeling systems

and tools supporting compliance and document traceability.

Key Competencies Strong scientific and analytical thinking. Excellent attention to detail and quality orientation. Ability to manage multiple projects and priorities effectively. Clear and professional communication with internal and external stakeholders. Proactive problem solving and decision making mindset. Collaborative customer focused and continuous improvement driven approach.