Jobs in Prague, Czechia

About the role

The Senior Regional Submissions Planner will work within our Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations department (RRO), supporting regional planning activities for the EU + EEMEA region while also contributing to cross-regional planning activities as needed. The Regional Submission Planner will support the regulatory submission plan creation and registration tracking of the company’s regulatory submission targets from a regional and cross-regional operational perspective. This role works closely with various stakeholders to drive the identification, planning, execution, and management of activities to deliver high quality and timely regulatory and safety submissions for approval. The incumbent is expected to demonstrate strong project management skills with the ability to operate in a multicultural environment and the ability to lead in a cross-functional setting.  Should be capable of independent management of all submission plans and documentation, at any level of complexity, across all submission types throughout the product lifecycle. Additionally, the incumbent may be involved in supporting internal or external process improvement or strategic initiatives. Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

What you'll bring

• Bachelor’s degree in a Life Science, Pharmacy or Engineering related discipline.
• At least 4  years’ experience in the pharmaceutical industry in operational roles, project management or regulatory affairs.
• Strong written and oral communication skills in English.
• Detail-Oriented, Drug Regulatory Affairs, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions
• Regulatory operations experience is preferred.
• Strong problem solving and critical thinking skills with the ability to analyze complex scenarios, design strategic solutions to navigate complex regulatory landscapes and drive informed decision making in dynamic-regulatory settings.
• Adaptable with the ability to adjust, modify, or change one's approach, behavior, mindset and/or plan in response to evolving priorities.
• Advanced ability to collaborate, interact, and negotiate effectively with internal and external stakeholders fostering alignment in cross-functional and multicultural environments.
• Ability to communicate effectively, both verbally and in writing across all levels and functional areas within the organization with strong stakeholder engagement.
• Excellent prioritization and organizational skills, with attention to detail and ability to manage competing priorities.
• Strong team facilitation skills with the ability to establish collaborative environments and drive alignment across deliverables.
• In-depth knowledge of regulatory frameworks, procedures and processes, especially within the EU + EEMEA region.

Benefits