REGULATORY AFFAIRS MANAGER, GLOBAL LABELLING
- Hiring from
- Austria
- Work type
- Remote
- Posted
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Regulatory Affairs Manager, Global Labelling
Location: Kundl, Tyrol
Category: Regulatory Affairs
Salary: Apply for details
Country: Austria
Employment: Contract
Worksite: On-Site
Apply For This Position
Job Description
Become a Catalyst for Global Healthcare Innovation as Our Regulatory Affairs Manager, Global Labelling
Are you ready to make a real difference in the world of healthcare by leading innovative global labelling strategies? Join us in this pivotal role where your expertise will directly impact patient access to vital medicines, ensuring compliance and clarity across diverse markets. Be part of a forward-thinking team dedicated to transforming healthcare through precision and regulatory excellence.
Overview
As our Regulatory Affairs Manager, Global Labelling, you will oversee and shape the global labelling strategies for biosimilars and other critical pharmaceuticals. This role offers the opportunity to work remotely, primarily from Austria, with some flexibility to attend the Kundl office. You will collaborate across regions to streamline labelling processes, manage regulatory documentation, and ensure adherence to EU and US regulatory standards.
Key Responsibilities
Take the next step in your career–apply now to be part of a team dedicated to making healthcare more accessible and innovative worldwide!
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Location: Kundl, Tyrol
Category: Regulatory Affairs
Salary: Apply for details
Country: Austria
Employment: Contract
Worksite: On-Site
Apply For This Position
Job Description
Become a Catalyst for Global Healthcare Innovation as Our Regulatory Affairs Manager, Global Labelling
Are you ready to make a real difference in the world of healthcare by leading innovative global labelling strategies? Join us in this pivotal role where your expertise will directly impact patient access to vital medicines, ensuring compliance and clarity across diverse markets. Be part of a forward-thinking team dedicated to transforming healthcare through precision and regulatory excellence.
Overview
As our Regulatory Affairs Manager, Global Labelling, you will oversee and shape the global labelling strategies for biosimilars and other critical pharmaceuticals. This role offers the opportunity to work remotely, primarily from Austria, with some flexibility to attend the Kundl office. You will collaborate across regions to streamline labelling processes, manage regulatory documentation, and ensure adherence to EU and US regulatory standards.
Key Responsibilities
- Lead global labelling activities, ensuring accurate, compliant, and market-specific product labelling for biosimilars in EU and US markets.
- Manage regulatory documentation and submissions, maintaining alignment with project timelines and regulatory requirements.
- Oversee and optimize labelling processes within Veeva platform systems, including Regulatory Management and Document Management.
- Coordinate with cross-functional teams to deliver consistent and compliant labelling content.
- Stay current with evolving regulations and guidance to proactively adapt labelling strategies.
- Support audit and inspection readiness related to labelling processes.
- Ensure all labelling activities meet quality, compliance, and business needs.
- Proven experience in Global Regulatory Labelling, especially within EU (Centralized Procedure for Biosimilars) and US (BLA).
- Hands-on experience with Veeva platform (Regulatory Management System & Document Management System).
- Ability to navigate complex regulatory environments, ensuring compliance across multiple regions.
- Strong coordination and communication skills to work effectively with global teams.
- Experience working within the biosimilar or pharmaceutical industry.
- Familiarity with remote working setups and digital collaboration tools.
- Knowledge of international regulatory frameworks beyond EU and US.
Take the next step in your career–apply now to be part of a team dedicated to making healthcare more accessible and innovative worldwide!
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.