Regulatory Affairs Manager

Regulatory Operations Manager– Labelling, Artwork & Translations
Regulatory Operations Manager– Labelling, Artwork & Translations
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.
we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. 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’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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 Operations (RO) Labeling Artwork and Translations (LAT) is a core function within Gilead's Global Regulatory Operations organization and acts as a critical strategic partner across cross-functional teams. RO LAT manages, updates, and maintains product information labeling and associated documentation, including translation and artwork for all Gilead products in applicable markets outside of the U.This includes managing and coordinating language translations of product information labeling and associated documentation and supporting development and maintenance of artwork through strong collaborative partnerships, as well as maintaining relevant processes and considering process improvements, to allow efficient and compliant work. RO LAT plays a key role in ensuring product information labeling and associated documentation is fully compliant with governing laws, regulations, and company policies and procedures, while being aligned with business goals and objectives, to facilitate effective review by health authorities and other stakeholders, as well as to avoid errors in product information labeling to protect patient safety. RO LAT works closely with cross-functional partners to ensure timely and appropriate delivery of product information labeling translations and artwork updates, including other Regulatory and Development teams, Legal, Commercial, and external third parties i.e., translation vendor and regulatory agencies.
You will manage a small to mid-size team of direct reports supporting translation and artwork activities involved in the preparation and maintenance of updates to ex-U.You will take the lead on preparation and maintenance of non-routine/more complex product labeling, artwork, and translation activities for assigned products in ex-U.You will be accountable to ensure timely, thorough, high quality, and compliant preparation, maintenance, and review of EU annexes and ex-U.S. labeling, including oversight of all support provided by your team in associated regulatory submissions. You will represent RO LAT on Regulatory Project Teams, in cross-functional submission team meetings, and on joint labeling/safety meetings with partner companies. You will contribute to the regulatory review of Annual Reports and safety reports as applicable. You will maintain awareness of regulatory intelligence and guidance, as this impacts product labeling, artwork, and translations, and educate internal/external partners on these matters and their evolution. You may also initiate process updates and/or other special projects.
Coaches direct reports on their performance, development and career interests.
Takes the lead on operational activities involved in label preparation for regulatory submissions in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
Working in conjunction with the Global TA Liaisons, may be responsible for implementing labelling changes, such as QRD updates or administrative changes, and completing applicable regulatory submissions, such as Closing Sequences, and ensuring product packaging and associated information is updated and maintained, in accordance with the product license for assigned products and markets.
Develops and manages relationships with translation vendor(s) and works in partnership with Third Parties to file, track, prepare, maintain, review, and deliver updated translations as required.
Ensures appropriate use and maintenance for artwork and translations systems.
Raises, informs, and resolves any issues that may impact labelling, translation, and artwork activities, including submission process or timelines, working with all applicable parties.
Reviews and maintains awareness of regulatory intelligence relating to labelling, translation, and artwork activities, e.g., changes to Regulatory Agency guidance such as template updates, and advises stakeholders accordingly.
May manage product information labeling translations and artwork documentation tracking and distribution, including filing, archiving, and retrieval.
Contributes to the definition, development, and implementation of processes and initiatives to meet the evolving needs of the RO LAT group.
Trains and advises new or less experienced colleagues in various RO LAT policies, practices, processes, systems, and other tools.
Adheres to regulatory requirements, industry standards and Gilead SOPs, and ensures the same across own team.
BA/ BS or advanced degree in life sciences or related field with significant regulatory or related experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Prescription drug labeling or related work experience.
In-depth knowledge of labeling, artwork, and translations regulations and guidance.
Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery, development, and commercial goals and objectives, including ICH standards and the regulatory requirements for assigned markets.
Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
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.YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
We promote and support individual differences and diversity of thoughts and opinion.
Full Time/Part Time Full-Time