Regulatory Associate - Promotional
ProClinical is advertising a vacancy for a Regulatory Associate -Promotional position with a leading multinational pharmaceutical company who is seeking an applicant to join their US site in New Jersey. The organization develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. This is an exciting opportunity to join a top 10 company and bolster your career in the Regulatory field.
- Preparing and compiling regulatory submissions, responding to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines.
- Supporting the development, translation (if relevant), review, and approval of artwork and promotional copy material to ensure regulatory compliance.
- Ensuring compliance with regulatory agency requirements and interpretations.
- Interacting with regulatory agency personnel in order to seek guidance, expedite approval of pending applications, and to resolve regulatory matters.
- Independently developing knowledge of current regulations for assigned area of responsibility.
- Monitoring regulatory environment for changes to requirements.
- Ensuring compliance within the department by ensuring local, regional, and global processes, policies, SOPs, and working instructions are adhered to.
- Updating relevant local databases to ensure compliance.
- Supporting the development of timelines for submissions and monitoring progress of applications against set timelines, acting where necessary to minimize delays.
- Maintaining and archiving regulatory documentation (as appropriate).
Skills and Requirements:
- A relevant university degree, or equivalent experience.
- Relevant regulatory experience.
- Strong planning skills to manage customer engagement.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Mid-Senior Level.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sarah Beshara at +267-477-3355 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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