Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team in Romania. This role can be either home or office based in Bucharest.
As a Senior Regulatory Affairs Associate, you will bring a few years of Regulatory Affairs experience gained in the industry. You will have experience in Clinical Trial Applications (CTA) from various European locations and will have the opportunity to work on submissions for Parexel as well as dedicated for clients.
Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the business and the client.
We will provide you with support of more senior staff to accomplish more complex tasks. You may act in a client-facing role with clear guidance and support from line management.
Key Responsibilities:
- Ensure client work is performed and delivered on time
- Meet quality expectations of the business and the client
- Work on Clinical Trial Applications (CTA) from various European locations
- Support more senior staff on complex tasks
Requirements:
- Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
- Few years of experience in an industry-related environment
- Experience in clinical trial submissions to the competent Regulatory Authorities
- Client-focused approach to work
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in English language
-
Regulatory Affairs Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States PAREXEL Full timeJob SummaryPAREXEL is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the timely performance of work within a project scope to the quality expectations of PAREXEL and our clients.Key ResponsibilitiesManage and coordinate the local regulatory submission strategy...
-
Regulatory Affairs Policy Specialist, Intel,
4 weeks ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Policy Specialist to join our team at Exelixis. The successful candidate will be responsible for gathering and interpreting global regulatory intelligence to inform Exelixis policy and practices.Key ResponsibilitiesEnsures timely preparation and completion of action plans to maintain Exelixis...
-
Senior Director, Commercial Regulatory Affairs
4 weeks ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director, Commercial Regulatory Affairs to join our team at Exelixis. This role will be responsible for providing strategic regulatory leadership in the areas of advertising and promotion, ensuring compliance with all FDA regulations, and providing regulatory guidance on the review and...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeThe Senior Director, Global Medical Affairs Pipeline Hematology is a key member of the Therapeutic Area Leadership Team (TALT), contributing to the cross-functional development of TA strategies and individual global product strategies.Main Responsibilities & AccountabilitiesOversees and directs pipeline TA Medical Directors' activities in developing and...
-
Cybersecurity Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States Regulatory DataCorp, Inc. Full timeRDC, a leading provider of Anti-Money Laundering, Know Your Customer, Anti-Bribery & Corruption solutions, is seeking a skilled Security Analyst to protect its clients from regulatory risks.The ideal candidate will have 1-3 years of experience in information security, with a strong understanding of threat models, methodologies, and industry compliance...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeThe Senior Director Medical Affairs Inline Bleeding will provide strategic medical leadership across all inline bleeding products. This role is critical to drive medical strategy and execution excellence, enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement, and product expertise.Main Responsibilities &...
-
Quality Assurance Automation Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States Regulatory DataCorp, Inc. Full timeJob SummaryRegulatory DataCorp, Inc. is seeking a skilled QA Automation Engineer to contribute to the Quality Control team. As a QA Automation Engineer, you will be involved in all phases of the software lifecycle, from planning to post-deployment testing. We are looking to expand our automated testing capabilities, so if you're passionate about test...
-
Senior Biostatistics Director
4 weeks ago
King of Prussia, Pennsylvania, United States Aequor Technologies Full timeJob SummaryAs a Senior Biostatistics Director at Aequor Technologies, you will lead late phase project and regulatory submissions, representing Biostatistics in interactions with regulatory authorities. You will define statistical strategy and ensure appropriate statistical methodologies are applied to study design and analysis for clinical trials.Key...
-
Regional Account Manager
4 weeks ago
King of Prussia, Pennsylvania, United States Clean Earth Holdings Full timeJob DescriptionThe Regional Account Manager will be responsible for expanding the Company's business within pre-assigned territories. This position is accountable for achieving sales goals through the acquisition and development of new customers and expansion of the product line within the existing customer base.Key ResponsibilitiesMaintains current...
-
Cybersecurity Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States Arka Service Full timeJob Title: Cybersecurity SpecialistJob Summary:Arka Service is seeking a highly skilled Cybersecurity Specialist to join our team. As a Cybersecurity Specialist, you will be responsible for ensuring the security and integrity of our systems and data. This is a challenging and rewarding role that requires a strong understanding of cybersecurity principles and...
-
Regional Business Development Manager
4 weeks ago
King of Prussia, Pennsylvania, United States Enviri Corporation Full timeJob DescriptionClean Earth is a leading provider of environmental services in the United States, offering remediation, disposal, recycling, and beneficial reuse solutions for hazardous and non-hazardous waste, contaminated soil, and dredged material.As a Regional Account Manager, you will be responsible for expanding the Company's business within...
-
Pediatric Care Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States Aveanna Healthcare LLC Full timeJob Title: Pediatric Care SpecialistWe are seeking a compassionate and dedicated Pediatric Care Specialist to join our team at Aveanna Healthcare LLC.Job Summary:The Pediatric Care Specialist will provide high-quality clinical care to patients in their homes, working closely with our interdisciplinary team to ensure coordinated and comprehensive care...
-
Fleet Maintenance Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States Cogent Analytics Full timeFleet Maintenance SpecialistAt Cogent Analytics, we are seeking a highly skilled Fleet Maintenance Specialist to oversee our fleet maintenance while supporting our rapid response and restoration services. The ideal candidate will have a strong background in commercial vehicle maintenance and maintenance schedules. Key responsibilities include:Fleet...
-
CQA Management/Audit Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States BioSpace, Inc. Full timeJob DetailsThe OpportunityClinical Quality Assurance (CQA) professionals play a vital role in ensuring the integrity and quality of clinical trials. As a CQA Management/Audit Specialist at BioSpace, Inc., you will be responsible for managing global CQA activities in various regions, including Asia-Pacific, Americas, EMEA, and Japan. Your primary focus will...
-
Senior QA GCP Manager
4 weeks ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob SummaryWe are seeking a highly skilled Senior QA GCP Manager to join our team at Exelixis. As a key member of our Quality Assurance team, you will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations.Key Responsibilities:Assist in the development of internal...
-
Pharmacy Technician
4 weeks ago
King of Prussia, Pennsylvania, United States Thomas Jefferson University & Jefferson Health Full timeAs a key member of our team at Thomas Jefferson University & Jefferson Health, the Pharmacy Technician - Wholesale Specialist will play a vital role in supporting our wholesale pharmacy operations. Key Responsibilities: Performs various technical and support duties under the supervision of a registered pharmacist. Assists with inventory management, including...
-
Industrial Mechanical Specialist
3 weeks ago
King of Prussia, Pennsylvania, United States Insight Global Full timeJob Summary: We are seeking a skilled Facilities Specialist to join our team at Insight Global. The successful candidate will be responsible for operating, maintaining, and repairing various utility equipment systems.Responsibilities:Operate and maintain steam boilers, deaerators, pumps, valves, and associated control systems.Operate and maintain chilled...
-
Clinical Research Associate I
4 weeks ago
King of Prussia, Pennsylvania, United States PAREXEL Full timeStudy Start Up Specialist - Join PAREXEL in this exciting opportunity to specialize in performing all study start up activities for a clinical trial.As a Clinical Research Associate I, you will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study.This role involves...
-
Pharmacovigilance Safety Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States Russell Tobin Full timeRussell Tobin is seeking a highly skilled Pharmacovigilance (PV) Safety Specialist to join their team near King of Prussia, PA.Key Responsibilities:Liaise with US Commercial and Global Commercial teams to inform the Safety Officer about new Organized Data Collection System (ODCS) programs.Maintain global ODCS entries for USA via HaloPV to ensure compliance...
-
Facilities Maintenance Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States Insight Global Full timeJob Summary:We are seeking a skilled Facilities Maintenance Specialist to join our team at Insight Global. The successful candidate will be responsible for the operation, maintenance, and repair of various utility systems, including steam boilers, chilled water systems, high purity water systems, and direct expansion air conditioning or refrigeration...