About Company
Propelling innovation forward demands meticulous attention to regulatory detail. At Career.zycto, we empower clients across the life sciences sector to navigate complex global compliance landscapes with precision and foresight. We’re a dynamic firm known for fostering an environment where regulatory experts, like yourself, thrive by tackling diverse challenges. Joining us means becoming a vital part of a collaborative team that values accuracy, strategic thinking, and continuous professional growth. We’re committed to delivering excellence, making us the ideal home for those passionate about ensuring product safety and market access.
Job Description
Are you a meticulous and experienced Regulatory Submission Specialist seeking an opportunity to leverage your expertise from anywhere? Career.zycto is on the lookout for a dedicated professional to join our dynamic, remote-first team. As a Regulatory Submission Specialist, you will be instrumental in preparing, compiling, and submitting high-quality regulatory dossiers to global health authorities. This pivotal role ensures our clients’ products meet stringent regulatory requirements, facilitating timely market access and continued compliance. You will work within a supportive and collaborative remote environment, where your contributions directly impact patient safety and public health.
This role demands a keen eye for detail, a thorough understanding of global regulatory frameworks (such as FDA, EMA, MHRA guidelines), and exceptional organizational skills. You will be responsible for managing submission timelines, coordinating with various cross-functional teams, and ensuring all documentation is accurate, complete, and formatted according to specific agency requirements. We are committed to fostering an environment of continuous learning and professional development, providing you with the resources and challenges to grow your career within the regulatory affairs domain. If you thrive in an autonomous yet collaborative setting and are passionate about the intricacies of regulatory submissions, we encourage you to apply. Join Career.zycto and help us make a significant impact on the future of healthcare innovation, all from the comfort of your home office.
Key Responsibilities
- Prepare, compile, and submit regulatory applications (e.g., MAAs, CTAs, INDs, NDAs, BLAs, variations, renewals) to global health authorities in accordance with applicable regulations and guidelines.
- Manage and track regulatory submission timelines, ensuring all deadlines are met efficiently.
- Coordinate with internal cross-functional teams (e.g., R&D, Clinical, Quality, Manufacturing) to gather necessary documentation and information for submissions.
- Conduct thorough quality control checks on submission documents for accuracy, completeness, and adherence to regulatory formatting requirements (e.g., eCTD, NeeS).
- Maintain up-to-date knowledge of relevant regulatory guidelines, laws, and health authority requirements across different regions.
- Respond to information requests from regulatory agencies and manage submission-related correspondence.
- Archive and maintain regulatory documentation and submission records in electronic document management systems.
- Contribute to the development and improvement of regulatory submission processes and procedures.
Required Skills
- Proven experience in regulatory submissions within the pharmaceutical, biotechnology, or medical device industry.
- In-depth understanding of global regulatory requirements, including FDA, EMA, and MHRA guidelines.
- Proficiency with electronic submission systems (e.g., eCTD publishing software) and document management systems.
- Exceptional attention to detail and strong organizational skills, capable of managing multiple projects simultaneously.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Demonstrated ability to work independently and collaboratively in a remote team environment.
- Strong problem-solving abilities and a proactive approach to regulatory challenges.
Preferred Qualifications
- Bachelor's degree or higher in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences).
- Certification in Regulatory Affairs (e.g., RAC).
- Experience with post-market submission activities and lifecycle management.
- Familiarity with various therapeutic areas and product types.
Perks & Benefits
- Competitive salary package commensurate with experience.
- Comprehensive health and wellness benefits, including private medical insurance.
- Flexible remote work environment, promoting work-life balance.
- Generous paid time off and public holidays.
- Professional development opportunities and support for continuous learning.
- State-of-the-art remote work tools and technology setup.
- Collaborative and supportive team culture, even when working remotely.
- Pension scheme contributions.
How to Apply
Ready to make a significant impact from your home office? We invite you to apply by clicking on the application link below. Please ensure your CV and cover letter highlight your regulatory submission expertise and your experience with remote work. We look forward to reviewing your application and exploring how your skills can contribute to our team at Career.zycto.
