Regulatory Affairs Lead
Gurgaon, Haryana Job ID R0173573 Category Research & Development Subcategory Research & Development Business Unit Global Portfolio Division Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
At Takeda, we are guided by our purpose of creating better health for people and a brighter future for the world. Every corporate function plays a role in making sure we — as a Takeda team — can discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
People join Takeda because they share in our purpose. And they stay because we’re committed to an inclusive, safe and empowering work environment that offers exceptional experiences and opportunities for everyone to pursue their own ambitions.
The Regulatory Operations, Senior Manager ensures that the organization gains regulatory approval for new products and product amendments while maintaining the currency of product licenses and permits. This role helps Takeda navigate complex regulatory landscapes, ensuring compliance and facilitating the successful launch and maintenance of products.
How you will contribute:
* Lead the process of regulatory compliance, ensuring all products meet external and internal standards
* Manage the submission of product notifications and approval applications effectively
* Conduct quality testing assessments to ensure compliance with regulatory requirements
* Interpret new regulations and evaluate their impact on company products and processes
* Provide expert advice and guidance on regulatory requirements for product development and marketing
* Represent the company effectively in discussions and negotiations with regulatory agencies
* Audit internal processes to ensure continuous compliance and identify areas for improvement
* Support product teams by offering insights into market analysis and customer needs during product development
* Analyze risks associated with regulatory non-compliance and develop mitigation strategies
* Manage complex projects within the regulatory framework, ensuring timely execution and compliance
* Demonstrate leadership in guiding and training junior staff in regulatory practices and standards
* Utilize strong project management skills to oversee regulatory projects and ensure alignment with organizational goals
Skills and qualifications:
* Leads the process of regulatory compliance, ensuring all products meet external and internal standards
* Manages the submission of product notifications and approval applications effectively
* Conducts quality testing assessments to ensure compliance with regulatory requirements
* Interprets new regulations and evaluates their impact on company products and processes
* Provides expert advice and guidance on regulatory requirements for product development and marketing
* Represents the company effectively in discussions and negotiations with regulatory agencies
* Audits internal processes to ensure continuous compliance and identifies areas for improvement
* Supports product teams by offering insights into market analysis and customer needs during product development
* Analyzes risks associated with regulatory non-compliance and develops mitigation strategies
* Manages complex projects within the regulatory framework, ensuring timely execution and compliance
* Demonstrates leadership in guiding and training junior staff in regulatory practices and standards
* Utilizes strong project management skills to oversee regulatory projects and ensure alignment with organizational goals
Takeda's Statement on Equal Employment Opportunity
It is the intent of Takeda to provide equal employment opportunity without regard to an individual’s age, color, disability, genetic information, marital status, national origin, citizenship status, race, religion, sex, sexual orientation, gender identity, protected veteran status or other legally protected category.
Takeda will consider all individuals for any position for which they are qualified and able to perform. It is also the policy of Takeda to administer all phases of its personnel activity, including recruitment, hiring, placement, upgrading, training, promotion, transfer, separation, recall, compensation, benefits, education, recreation, and all other conditions or privileges of employment without regard to age, color, disability, genetic information, marital status, national origin, citizenship status, race, religion, sex, sexual orientation, gender identity, protected veteran status or other legally protected category. Sexual harassment or any other kind of harassment including harassment based on sexual orientation and/or gender identity will not be tolerated.
