Publié il y a 21 jours
Senior Project Manager, Regulatory Affairs
@ Veristat, LLC
Québec
En bref
Veristat, LLC is hiring a Senior Project Manager, Regulatory Affairs to plan and execute regulatory projects and lead teams across consulting areas including CMC, quality, regulatory, clinical and business. The role is full-time with a hiring range of $128 to $144K plus bonus, and the posting states benefits and a 70% remote workforce.
Responsabilités :
- Plan, prepare and execute high quality regulatory projects
- Interface with internal departments, company leadership, sponsors and vendors
- Integrate consulting activities across CMC, quality, regulatory, clinical and business
- Build and motivate project teams and make decisions
Résumé des exigences :
- Bachelor's degree in life or health sciences or equivalent
- 6 to 8 years of regulatory experience at a CRO or pharma company
- 3 years of project management or functional team lead experience
- Knowledge of ICH guidelines and drug development process
- Excellent written and oral communication skills
Outils et compétences
Avantages mentionnés
Source et dates
Site carrière / système de candidatures · workday
- Date publiée par l’employeur
- 2026-10-20
- Première détection par notre source
- 2026-10-22
- Mise à jour du dossier source
- 2026-11-10
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Senior |
| Domaine | Opérations |
| Expérience | 6 an(s) et plus |
| Expérience en gestion | 3 an(s) et plus |
| Gestion d’équipe | Oui |
| Heures par semaine | 40 (estimé) |
| Milieu de travail | Domicile, Bureau |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English |
| Formation | Baccalauréat (exigé) |
| Domaines d’études | Life sciences, Health sciences |
| Avantages mentionnés | Congés payés généreux, Horaire flexible, Régime de retraite, Aide aux études |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
Veristat, LLC
Profil d’entreprise sauvegardé
Renseignements historiques provenant d’un profil The Jobs API sauvegardé (champs LinkedIn/Crunchbase). Ils ne sont pas vérifiés en temps réel; les chiffres peuvent avoir changé. Les valeurs manquantes restent inconnues.
Description complète de l’entreprise
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases. We are…Bold. Scientific. Versatile. Veristat. - Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant.
- Abonnés LinkedIn
- 32 931
- Personnes associées sur LinkedIn
- 494
- Bureaux déclarés
- 134 Turnpike Rd, Ste 200, Southborough, Massachusetts 01772, US
- 2801 Slater Road, Ste 100, Morrisville, North Carolina 27560, US
- TAIPEI, Hsin Ji 9F-1., No.460, Sec. 4 Xinyi Rd., Xinyi Dist., Taipei City, 11052, TW
- 36 rue de l'intendance, Lotissement de l'intendance, Fréjus, 83600, FR
- Carrer de Sant Antoni, Maria Claret 167, Barcelona, 08025, ES
- Aeschenvorstadt 52, Basel, CH-4051, CH
- Catégories d’activité
- Life Science
- Medical
- Pharmaceutical
- Autres noms enregistrés
- Veristat
- Spécialités
- Strategic Consulting
- Safety Management
- Data Management
- Biostatistics
- Statistical Programming
- Project Management
- Medical Writing
- Regulatory Submissions
- Adaptive Clinical Trial Design
- Site Monitoring
- Regulatory Consulting
- Clinical Trial Patient Recruitment
- Clinical Trial Data Standardization
- Clinicl Trial Design
- Clinical Trial Management
- US Regulatory Agent
- Pharmacovigilance
- Marketing Applications Support
- IND Support
- Regulatory Publishing
- Biologic
- Gene Therapy
- Full-service CRO
- and Oncology Clinical Trials
- Le profil indique une agence de recrutement
- Non
- Investissement total déclaré
- 0
La devise et la date d’observation ne sont pas fournies; ce n’est ni une valorisation actuelle ni une ronde de financement.
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and…
| Champ | Valeur |
|---|---|
| Secteur | Research Services |
| Taille | 501-1,000 employees |
| Siège social | Southborough, Massachusetts |
| Type d’organisation | Privately Held |
| Spécialités | Strategic ConsultingSafety ManagementData ManagementBiostatisticsStatistical ProgrammingProject ManagementMedical WritingRegulatory SubmissionsAdaptive Clinical Trial DesignSite Monitoring |
| Offres sur Jobsy | 3 |
| Voir la page |
Job Description:
Senior Project Manager, Regulatory Affairs
The Senior Project Manager, Regulatory Affairs provides management and leadership to plan, prepare, and execute high quality projects. S/he interfaces with internal departments and company leadership, and externally with sponsors and vendors. The Senior Project Manager, Regulatory Affairs will integrate consulting activities and assignments across all areas of consulting conducted (CMC, quality, regulatory, clinical and business) in coordination with other teams.
Make an Impact at Veristat!
Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.
- 105+ approved therapies for marketing applications prepared by Veristat
- 480+ oncology projects in the past 5 years
- 350+ rare disease projects delivered in the past 5 years
- Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
- Learn more about our core values here!
What we offer:
The estimated hiring range for this role is $128 – 144K plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
- Benefits vary by location and may include:
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
What we look for:
- Bachelor’s degree in life/health sciences or related discipline, or equivalent required.
- 6 to 8 years of relevant Regulatory experience in a Clinical Research Organization/Pharmaceutical Company, with a minimum of 3 years of Project Management or functional team lead experience required. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis.
- Excellent written and oral communication and interpersonal skills, as well as strong planning and organizational ability are required.
- Good working knowledge of drug development process and regulatory requirements, including familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines.
- Proficiency in English (written and verbal).
- Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions.
- Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
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Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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