A regulatory consultancy firm supporting startups specializing in drugs, biologics and innovative medical devices is seeking a new team player for the RA department with experience in the medical device field and/or the pharmaceutical development and regulations.
The candidate will provide RA consulting services to meet client expectations by supporting the design and development of products from regulatory, nonclinical, and clinical perspectives, developing global regulatory strategies, and writing and managing regulatory submissions. Reporting to RA Director.
The candidate will need to:
·Demonstrate a rapid learning curve and will be required to write English proficient regulatory documents.
·Submissions and communication with authorities worldwide.
·Coordinate and prepare regulatory packages for US and EU regulatory authorities.
·Interacting with CROs both on a local and global level.
·Acting as an operational delegate of the customer for diverse activities.
RA Consultant
- posted:
Job description:
Required qualifications:
Required Knowledge, Skills, and Abilities:
• M.Sc. or Ph.D. in Life Sciences/Biotechnology & Biomedical Engineering with 3-5 years of experience in pharmaceutical or medical device regulations
• Familiar with the EU new MDR- advantage
• Enthusiastic and eager to learn new development technologies and products
• Ability to work in multidisciplinary work opposite various stakeholders internally and externally.
• Excellent verbal and written communication skills enabling interacting with customers with a service-oriented attitude, understand customer needs and challenges, and adapting accordingly.
• Self-learner
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Experience in interacting with QA, QC, and CMC teams- advantage.
• Ability to capture both the "big picture" and technical details.
• Ability to adhere to timelines, act with a sense of urgency in an environment requiring rapid and prompt responses.