{"id":3597893,"url":"https://alion.io/job/lifelancer-manager-regulatory-affairs-emea-remote","title":"Manager, Regulatory Affairs - EMEA- Remote","company":{"id":3853997,"name":"Lifelancer","domain":"lifelancer.com","url":"https://alion.io/company/lifelancer","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":true,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"remote","remote_scope":"stated_regions","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":[],"countries":[],"hiring_countries":["DE","FR","AE","GB","AT","BE","BA","BG","HR","CY","CZ","DK","FI","HU","IE","IL","IT","KE","ME","NL","NG","NO","PL","RO","SA","RS","ZA","ES","SE","CH","TR","UA","AL","DZ","AD","AO","BH","BJ","BW","BF"],"hiring_countries_total":116,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-11-01T12:50:46Z","employer_posted_date":null,"last_verified_at":"2026-11-01T12:50:46Z","board_verified":false,"closed_at":null,"days_open":2,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":2},"description":"Job Title: Manager, Regulatory Affairs - EMEA- Remote\nJob Location: Bucuresti, Romanina\nJob Location Type: Remote\nJob Contract Type: Full-time\nJob Seniority Level: 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.\nWe 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.\nOur mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.\nWhy 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!\nWhat the Regulatory Affairs department does at the Worldwide\n\nRegulatory 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 process\n\nWhat you will do\nReview 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 needs\n\nCoordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions\n\nProvide 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 requirements\n\nProvide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff\n\nWhat you will bring to the role\nClearly, proven leadership and organizational management skills are essential attributes\n\nStrong planning, strategizing, managing, monitoring, scheduling, and critiquing skills\n\nExcellent written and verbal communication skills to clearly and concisely present information\n\nRelationship-building competency combined with demonstrated comfort supporting Business Development at a face-to-face meeting\n\nStrong interpersonal skills in a fast-paced, deadline-oriented, and changing environment\n\nExcellent ability to handle multiple tasks in a fast-paced and constantly changing environment\n\nYour experience\nA minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…\n\nTwo-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience within clinical research (e.g., CRA, Reg Affairs)\n\nMinimum 5-7 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience\n\nProficient in cross-cultural communication and proficient in both spoken and written English\n\nWe love knowing that someone is going to have a better life because of the work we do. \nTo view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn. \nWorldwide 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. \n\nThis job is curated by Lifelancer.Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.\nPlease apply via Lifelancer platform to get connected to the application page and to find similar roles.\nOriginally posted on Himalayas","description_format":"text","description_chars":5826,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Germany","iso":"DE","kind":"region"},{"name":"France","iso":"FR","kind":"region"},{"name":"United Arab Emirates","iso":"AE","kind":"region"},{"name":"United Kingdom","iso":"GB","kind":"region"},{"name":"Austria","iso":"AT","kind":"region"},{"name":"Belgium","iso":"BE","kind":"region"},{"name":"Bosnia and 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