Senior/Regulatory Affairs Manager- APAC- Remote
Opportunité Professionnelle : Senior/Regulatory Affairs Manager – APAC – Remote
Présentation de l’Entreprise
Worldwide Clinical Trials est une organisation de recherche clinique (CRO) de taille moyenne, résolue à transformer le paysage des essais cliniques. Avec une équipe de plus de 3 500 experts, cette entreprise innove constamment en cherchant à améliorer la vie des patients atteints de maladies persistantes. La vision de Worldwide repose sur une approche audacieuse et créative, favorisant un environnement où chaque membre peut jouer un rôle déterminant.
Mission de l’Entreprise
L’entreprise s’engage à favoriser un environnement de travail inclusif et diversifié, où l’égalité des chances est une priorité. Les valeurs fondamentales de Worldwide Clinical Trials soulignent l’importance de la collaboration, de l’excellence et du soutien mutuel, permettant ainsi à tous les professionnels de contribuer à faire une différence significative pour les patients et leurs familles.
Rôle du Département d’Affaires Réglementaires
Le département des affaires réglementaires intervient dans un domaine vital, naviguant à travers les complexités des réglementations en matière de recherche clinique. Ce service est chargé de :
- Soumissions aux autorités réglementaires : Garantir la conformité aux règlements en vigueur.
- Coordination avec les comités d’éthique : Faciliter les approbations nécessaires à l’échelle régionale (EMEA, Asie-Pacifique et Amérique Latine).
- Mentoring et formation : Apporter son expertise aux membres moins expérimentés de l’équipe.
Responsabilités du Poste
En tant que Senior/Regulatory Affairs Manager, les missions principales comprendront :
- Obtention d’approbations réglementaires : Gérer les soumissions et maintenir les approbations dans plusieurs régions.
- Conseils réglementaires : Offrir des consultations stratégiques sur la conformité des produits médicaux.
- Préparation de la documentation technique : Contribuer au développement et à la révision des documents nécessaires tels que les IMPDs et IBs.
- Gestion d’équipe : Former et coacher des membres juniors tout en assurant une communication efficace avec les parties prenantes.
Profil Recherché
Candidates et candidats plus que qualifiés sont attendus. Les exigences incluent :
- Formation et expérience : Un diplôme supérieur (bac+4 minimum) en sciences de la santé ou un domaine connexe avec au moins cinq ans d’expérience dans l’industrie pharmaceutique ou CRO.
- Compétences essentielles : Capacités avérées en gestion de projet, communication et développement des affaires.
- Talent interpersonnel : Aptitude à établir des relations fructueuses et à travailler dans des environnements dynamiques.
Engagement d’Égalité des Chances
Worldwide Clinical Trials se distingue par son engagement en faveur de l’inclusion, refusant toute forme de discrimination. La société encourage les candidatures de personnes provenant de toutes horizons et s’engage à embaucher les meilleurs talents, quelles que soient leurs origines.
Processus de Candidature
Pour en savoir plus sur le poste et postuler, veuillez suivre ce lien : Postulez dès maintenant.
Avec cette opportunité, vous pourriez jouer un rôle essentiel dans le changement des vies des patients à travers le monde.
📅 Date de publication de l’offre : Sat, 21 Jun 2025 23:54:48 GMT
🏢 Entreprise : Worldwide Clinical Trials
📍 Lieu : 한국
💼 Intitulé du poste : Senior/Regulatory Affairs Manager- APAC- Remote
💶 Rémunération proposée :
📝 Description du poste : Who we areWe’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!What the Regulatory Affairs department does at the WorldwideRegulatory Affairs plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission processWhat you will doReview study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needsCoordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissionsProvide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirementsProvide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staffWhat you will bring to the roleClearly, proven leadership and organizational management skills are essential attributesStrong planning, strategizing, managing, monitoring, scheduling, and critiquing skillsExcellent written and verbal communication skills to clearly and concisely present informationRelationship-building competency combined with demonstrated comfort supporting Business Development at a face-to-face meetingStrong interpersonal skills in a fast-paced, deadline-oriented, and changing environmentExcellent ability to handle multiple tasks in a fast-paced and constantly changing environmentYour experienceA minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years experience within clinical research (e.g. CRA, Reg Affairs.)Minimum 5 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experienceProficient in cross-cultural communication and proficient in both spoken and written EnglishWe love knowing that someone is going to have a better life because of the work we do.To view our other roles, check out our careers page at ! For more information on Worldwide, visit or connect with us on .Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
🔎 Offre d’emploi vérifiée et enrichie selon la ligne éditoriale de l’Association Artia13 : éthique, inclusion, transparence et vigilance contre les annonces trompeuses.
🌍 Retrouvez d’autres offres sur artia13.world
