Verified Job
Digital Marketing
Global Regulatory Professional
Digital Marketing
#320650
Remote / WFH
Job Description
Job Description Summary
As a Global Regulatory Affairs professional with expertise within Regulatory Affairs marketed products you will be supporting Marketing Authorisation activities from a full lifecycle management perspective, offering technical expertise and obtaining relevant approvals where required. You will be responsible for providing support to regulatory submissions in an efficient and timely manner through cross collaboration with multiple stakeholders and uphold “right first time” submission quality and timeliness.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and Responsibilities
In this role you will:
Interpret regulations, guidelines and requirement and act as a Regulatory expert responsible for complete lifecycle management of submissions MAA - Marketing Authorization Application (various European procedures, ROW - Rest of the World, MAAs), Renewals (Europe and Non-Europe) and variations (RA - Regulatory Activities such as Safety updates, Labelling updates, administrative updates. & Quality variations) starting from strategic discussions with cross-functional teams (internal & third party), preparation of packages in line with regulations, coordinating with the CMC - Chemistry Manufacturing Control team to get CMC documentation and also with the publishing team to get the output ready as per market need, dispatch to markets, follow-up submissions until made and track until approval.
Work closely with line manager and Global Regulatory product leads (GRPL), as directed, to ensure that submission strategies are executed as per HA requirements to achieve efficient positive outcomes.
Be responsible for ensuring information relating to allocated submissions is uploaded into the Regulatory information management database as per the standard documented procedures.
Ensure that relevant KPIs within the lifecycle of regulatory submissions, as defined in standard procedures, are met.
Work with cross functional teams as needed, to plan and execute regulatory submissions.
Participate in projects related to improving the processes, standards, and learning sharing.
Escalate issues/risk to regulatory submissions at the right time with sufficient information.
Support global regulatory or technical initiatives or act as a representative on behalf of regulatory team, as needed.
Write or review regulatory standard operating procedures or cross functional procedures, as needed.
Required Qualifications
Bachelor’s degree in life sciences or related discipline
Extensive Regulatory Affairs experience is essential in pharmaceutical or radiopharmaceuticals domain, with knowledge of regulatory requirements in major regions (Europe, United States, and Rest of the World) both in CMC and RA submissions
Adept at Regulatory strategy and/or submission execution
Expert in planning and delivering work on time keeping first time quality in mind
Hands-on experience with Regulatory information management systems (e.g., Veeva Vault) would be a plus.
Willing to travel when required, but not more than 5-10%
Desired Characteristics
Strong interpersonal skills and ability to engage effectively with colleagues at all levels
Ability to resolve day-to-day issues, escalating issues that impact strategic initiatives
Experience working with outsource partners an advantage
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, ****** orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-LM1
Additional Information
Relocation Assistance Provided: No
As a Global Regulatory Affairs professional with expertise within Regulatory Affairs marketed products you will be supporting Marketing Authorisation activities from a full lifecycle management perspective, offering technical expertise and obtaining relevant approvals where required. You will be responsible for providing support to regulatory submissions in an efficient and timely manner through cross collaboration with multiple stakeholders and uphold “right first time” submission quality and timeliness.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and Responsibilities
In this role you will:
Interpret regulations, guidelines and requirement and act as a Regulatory expert responsible for complete lifecycle management of submissions MAA - Marketing Authorization Application (various European procedures, ROW - Rest of the World, MAAs), Renewals (Europe and Non-Europe) and variations (RA - Regulatory Activities such as Safety updates, Labelling updates, administrative updates. & Quality variations) starting from strategic discussions with cross-functional teams (internal & third party), preparation of packages in line with regulations, coordinating with the CMC - Chemistry Manufacturing Control team to get CMC documentation and also with the publishing team to get the output ready as per market need, dispatch to markets, follow-up submissions until made and track until approval.
Work closely with line manager and Global Regulatory product leads (GRPL), as directed, to ensure that submission strategies are executed as per HA requirements to achieve efficient positive outcomes.
Be responsible for ensuring information relating to allocated submissions is uploaded into the Regulatory information management database as per the standard documented procedures.
Ensure that relevant KPIs within the lifecycle of regulatory submissions, as defined in standard procedures, are met.
Work with cross functional teams as needed, to plan and execute regulatory submissions.
Participate in projects related to improving the processes, standards, and learning sharing.
Escalate issues/risk to regulatory submissions at the right time with sufficient information.
Support global regulatory or technical initiatives or act as a representative on behalf of regulatory team, as needed.
Write or review regulatory standard operating procedures or cross functional procedures, as needed.
Required Qualifications
Bachelor’s degree in life sciences or related discipline
Extensive Regulatory Affairs experience is essential in pharmaceutical or radiopharmaceuticals domain, with knowledge of regulatory requirements in major regions (Europe, United States, and Rest of the World) both in CMC and RA submissions
Adept at Regulatory strategy and/or submission execution
Expert in planning and delivering work on time keeping first time quality in mind
Hands-on experience with Regulatory information management systems (e.g., Veeva Vault) would be a plus.
Willing to travel when required, but not more than 5-10%
Desired Characteristics
Strong interpersonal skills and ability to engage effectively with colleagues at all levels
Ability to resolve day-to-day issues, escalating issues that impact strategic initiatives
Experience working with outsource partners an advantage
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, ****** orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-LM1
Additional Information
Relocation Assistance Provided: No
