About Company
Empowering talent through strategic placements, Career.zycto is dedicated to connecting top-tier professionals with innovative companies across the globe. We believe in fostering environments where individuals can thrive and make a tangible impact. For a Regulatory Affairs Specialist, our partnerships mean access to diverse projects and forward-thinking organisations committed to compliance and scientific integrity. We empower our candidates to shape their careers, offering roles that align with their expertise and growth ambitions in the dynamic life sciences sector.
Job Description
Are you a meticulous and experienced Regulatory Affairs Specialist seeking a challenging yet flexible role? Career.zycto is excited to partner with a leading organisation in the pharmaceutical and medical device sector to recruit a dedicated Work from Home Regulatory Affairs Specialist. This pivotal role offers the opportunity to apply your expertise in a dynamic, remote environment, contributing significantly to product lifecycle management and market access across the UK and potentially the wider EU.
In today’s rapidly evolving regulatory landscape, staying ahead is not just an advantage—it’s a necessity. We are looking for an individual who can navigate complex regulatory frameworks with precision, ensuring all submissions are compliant, timely, and of the highest quality. This remote position is perfect for a self-starter who thrives on autonomy, possesses exceptional analytical skills, and has a proven track record in regulatory submissions and strategy. You will be instrumental in guiding products from development through to post-market surveillance, ensuring adherence to national and international regulations such as MHRA, EMA, and other relevant bodies. Your daily work will involve critical analysis of regulatory intelligence, interpreting new guidelines, and developing strategic approaches to product registration and maintenance.
This is more than just a job; it’s an opportunity to join a team that values expertise, innovation, and ethical practice. Working from the comfort of your home base in Paisley, Glasgow, you will collaborate with cross-functional teams, including R&D, Quality Assurance, and Commercial, providing expert regulatory guidance. Your contributions will directly impact patient safety and product success, making this a truly rewarding role for a dedicated professional. We are committed to supporting our remote workforce with robust tools, resources, and a collaborative virtual environment to ensure your success. This role demands a proactive approach to problem-solving and an unwavering commitment to detail, ensuring that our client’s products meet the highest standards of safety, efficacy, and quality. You will be a key player in bridging the gap between scientific innovation and regulatory requirements, fostering a culture of compliance throughout the product lifecycle. If you are passionate about regulatory compliance and ready to take on a role that offers significant responsibility and professional growth, we encourage you to apply.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers for new products, variations, and renewals to relevant authorities (e.g., MHRA, EMA) in accordance with applicable guidelines.
- Develop and implement robust regulatory strategies to ensure timely product approvals and ongoing compliance with evolving regulations.
- Monitor, interpret, and disseminate new regulatory guidelines and provide strategic advice to internal teams on their impact.
- Manage regulatory aspects of the entire product lifecycle, including post-market surveillance, adverse event reporting, and promotional materials review.
- Act as a key contact point with regulatory authorities for assigned products and projects, fostering effective communication.
- Collaborate extensively with R&D, Quality Assurance, Marketing, and Legal departments to integrate regulatory requirements throughout product development and commercialization.
- Maintain accurate, comprehensive, and up-to-date regulatory documentation and databases, ensuring audit-readiness.
- Participate actively in regulatory intelligence gathering, contribute to internal training programs, and stay abreast of industry best practices.
Required Skills
- Minimum of 3 years of hands-on experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry.
- In-depth and practical knowledge of UK and EU regulatory frameworks (e.g., MHRA, EMA guidelines, GxP).
- Proven experience in preparing, compiling, and submitting regulatory dossiers (e.g., Marketing Authorisation Applications, variations, renewals) in eCTD format.
- Exceptional written and verbal communication skills in English, with the ability to articulate complex regulatory concepts clearly.
- Strong analytical, critical thinking, problem-solving, and organizational skills, with meticulous attention to detail.
- Demonstrated ability to work independently, manage multiple priorities, and meet strict deadlines in a remote work setting.
- Proficiency with regulatory databases, electronic document management systems, and eCTD submission software.
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences, Pharmacology).
Preferred Qualifications
- Master's degree or PhD in Regulatory Affairs, Pharmaceutical Sciences, or a closely related field.
- Experience with global regulatory submissions (e.g., FDA, Health Canada, TGA) is a plus.
- Familiarity with medical device regulations (e.g., MDR, IVDR) in addition to pharmaceutical experience.
- Professional certification in Regulatory Affairs (e.g., RAC from RAPS).
- Prior experience working with cross-functional international teams in a virtual environment.
Perks & Benefits
- Highly competitive salary commensurate with experience, along with performance-based bonuses.
- Comprehensive health and wellness benefits package, including private medical insurance.
- Generous paid time off, including annual leave and public holidays.
- Flexible work-from-home arrangement, promoting work-life balance.
- Extensive opportunities for continuous professional development, training, and career advancement.
- Access to a supportive, collaborative, and inclusive remote team environment.
- Allowance for home office setup and necessary equipment.
- Employee assistance program offering confidential support and resources.
How to Apply
Interested candidates are invited to submit their comprehensive CV and a tailored cover letter outlining their relevant experience, specific achievements in regulatory affairs, and why they are an ideal fit for this remote role. Please highlight your in-depth experience with UK/EU regulatory submissions. Click the application link below to proceed with your application.
