Manage product labeling and artwork for regulatory compliance, lead projects, ensure communication with stakeholders, and advocate for labeling initiatives.
Use Your Power for Purpose
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines .
What You Will Achieve
You will lead the development and maintenance of product labeling and artwork for regulatory compliance and commercialization. You will serve as a regulatory liaison between markets, manufacturing plants, and project teams, providing strategic direction and ensuring compliance with regulations.
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines .
What You Will Achieve
You will lead the development and maintenance of product labeling and artwork for regulatory compliance and commercialization. You will serve as a regulatory liaison between markets, manufacturing plants, and project teams, providing strategic direction and ensuring compliance with regulations.
- Provide guidance, lead/co-lead projects, and manage time to meet objectives .
- Support the development of tools and processes for global label development and approval.
- Plan, prioritize, and deliver labeling documents according to targets and requirements.
- Communicate and present information effectively to stakeholders.
- Develop local labeling documents with strategic and medical input.
- Review and implement labeling updates, recording key decisions.
- Serve as an SME for relevant tools and technologies in label development.
- Ensure compliance with internal SOPs and regulatory requirements.
- Contribute to continuous improvement of business practices.
- Advocate for new labeling initiatives to stakeholders.
Here Is What You Need (Minimum Requirements)
- BA/BS with 4 or more years of experience, or MBA/MS with 2 or more years of experience, or PhD/JD with 0 or more years of experience
- Strong understanding of regulatory submission processes and requirements.
- Demonstrated attention to detail and problem-solving skills.
- Knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
- Understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.
- Excellent written and verbal communication skills essential.
- Proven project management skills with the ability to lead complex projects.
Bonus Points If You Have (Preferred Requirements)
- Experience in the pharmaceutical industry.
- Exceptional organizational skills and attention to detail.
- Effective problem-solving and negotiation skills.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
Top Skills
Labeling Tools And Technologies
Regulatory Compliance Tools
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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