Senior Regulatory Executive, Regulatory Affairs
2 weeks ago
Executive Director, Regulatory Affairs Labeling
Executive Director, Regulatory Affairs Labeling
United Kingdom - Uxbridge, United Kingdom - Cambridge Regulatory Regular Job Description
For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.
Regulatory Affairs (RA) Labeling
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.
You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations / compliance. You will provide strategic input and operational leadership and management oversight of regulatory labeling across Gilead's product portfolio. You will oversee or otherwise lead labeling discussions in cross-functional governance and decision-making meetings. You will oversee or otherwise lead the establishment and maintenance of processes for ensuring global labeling compliance based on internal and external standards.
You will be a member of the Innovation, Content, and Operations (ICO) Regulatory Affairs Leadership Team with considerable responsibilities to develop, continuously improve and innovate global regulatory and labeling policies, practices, processes, tools, team, and other capabilities.
Leads the GRA Labeling function to ensure compliance with evolving global regulatory requirements and in support of company objectives.
Accountable for driving an effective and integrated cross functional governance that crosses organizational boundaries.
Leads a team of labeling operations and compliance specialists.
Oversee the development and management of implementation of global labeling and review processes, metrics, and systems. Represents the GRA Labeling function globally and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives and providing expertise in global labeling best practices.
Coaches and mentors team on their performance, development, and career interests.
Ensures the GRA Labeling team prepares timely, high-quality labeling documents in accordance with applicable regulations and the company position, and in close collaboration with cross-functional global and regional stakeholders, to support regulatory filings and labeling discussions with Health Authorities.
Leads or otherwise oversees Global Safety and Labeling Committee (GSLC) labeling governance discussions. Influences strategic or corporate direction through GSLC labeling agenda topics and background documents, by facilitating GSLC labeling discussions, and by building consensus with cross-functional leaders.
Owns and manages the resource plans, performance, and budget for the GRA Labeling function.
Drives digital innovation across the global labeling value chain.
PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience.
Extensive experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional leaders and teams for multiple medicinal products.
Extensive experience and significant successes setting and directing the regulatory labeling or related strategy to successful conclusion for multiple products.
Strong track record of successes working and negotiating with regulatory authorities.
Extensive experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.
Has multiple years’ line management (direct reports) experience. Leadership experience with high complexity, cross-functional initiatives, including team and governance management, strategy setting, and effective oversight of strategy execution.
Significant experience driving inspection readiness and quality processes across the end-to-end labeling process.
Extensive experience leading labeling transformations across organizational boundaries at global scale.
Extensive experience interacting with and presenting to executives and managing large-scale project budgets and other resources.
Expert-level knowledge in global labeling regulatory requirements and strategy, including industry best practices and standards.
Expert-level knowledge in labeling operations compliance, including quality management processes and systems.
In-depth knowledge of systems, tools, metrics, and digital technologies to support global labeling.
Recognized as a regulatory expert.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
When needed, ability to travel.
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.We promote and support individual differences and diversity of thoughts and opinion.
-
Senior Regulatory Affairs Specialist
1 month ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
4 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
3 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
3 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Senior Regulatory Affairs Specialist
3 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Regulatory Specialist
1 month ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...
-
Regulatory Specialist
2 months ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...
-
Regulatory Specialist
2 months ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...
-
Regulatory Specialist
2 months ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...
-
Regulatory Specialist
2 months ago
United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...
-
Regulatory Specialist and Senior Specialist
3 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Regulatory Specialist and Senior Specialist
3 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Regulatory Specialist and Senior Specialist
3 weeks ago
United Kingdom Mosaic Regulatory Solutions Full timeThis global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...
-
Regulatory Affairs Executive
1 month ago
United Kingdom Callisto Pharma Group Full timeRegulatory Affairs Executive Due to continued expansion and new Client projects we are currently seeking an additional Regulatory Affairs Executive to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key...
-
Senior Regulatory Affairs Specialist
6 days ago
United Kingdom Corin Group Full timeSenior Regulatory Affairs Specialist to work at Corin, you will be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to...
-
Senior Regulatory Affairs Specialist
6 days ago
United Kingdom Corin Group Full timeSenior Regulatory Affairs Specialist to work at Corin, you will be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to...
-
Senior Regulatory Affairs Specialist
7 days ago
United Kingdom Corin Group Full timeSenior Regulatory Affairs Specialist to work at Corin, you will be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to...
-
Regulatory Affairs Specialist
2 months ago
United Kingdom Corin Group Full timeCorinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #233 04 April 2024 Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards,...
-
Senior Director Regulatory Affairs
3 weeks ago
United Kingdom Vector - Talent Solutions for the Pharmaceutical Supply Chain Full timeSenior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at...
-
Senior Director Regulatory Affairs
3 weeks ago
United Kingdom Vector - Talent Solutions for the Pharmaceutical Supply Chain Full timeSenior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...
