As a Regulatory Affairs Specialist at MakroCare, you will be responsible for managing and overseeing regulatory submissions and communications with drug regulatory authorities. This includes ensuring compliance with CMC, eCTD/CTD requirements, and staying abreast of regulatory changes in the US, UK, EU, and ROW (Rest of the World) markets. The ideal candidate will have a strong background in regulatory publishing and submission processes and will play a crucial role in maintaining the high standards of MakroCare’s regulatory operations.
Key Responsibilities:
- Prepare and review regulatory submissions in compliance with CMC, eCTD/CTD requirements.
- Ensure timely and accurate submissions to regulatory authorities in the US, UK, EU, and ROW markets.
- Monitor and interpret regulatory requirements and guidelines.
- Ensure compliance with all relevant regulatory standards and policies.
- Expertly handle the publishing and submission of regulatory documents.
- Manage and maintain submission tracking systems.
- Develop and implement regulatory strategies to ensure successful registration and maintenance of products.
- Liaise with regulatory authorities and provide strategic guidance on regulatory matters.
- Work closely with cross-functional teams including R&D, Quality Assurance, and Clinical Development.
- Provide regulatory support and guidance throughout the product lifecycle.
- Maintain accurate and up-to-date regulatory documentation and records.
- Prepare reports and documentation for internal and external audits.
Eligibility Criteria:
Education:
- Bachelor’s or Master’s degree in Life Sciences, B Pharmacy, or M Pharmacy.
Experience:
- 4-8 years of experience in Regulatory Affairs, specifically within the Healthcare, Clinical Research, Biotech, Biopharma, or Medical Device industries.
- Extensive experience with CMC, eCTD/CTD requirements.
- Proven expertise in regulatory publishing and submission processes.
- Strong understanding of regulatory requirements in the US, UK, EU, and ROW markets.
Skills And Abilities:
- Strong analytical and problem-solving skills.
- Excellent written and oral communication skills.
- Detail-oriented with a strong focus on compliance and quality.
- Ability to manage multiple projects and deadlines.
- Proficiency in regulatory submission software and tools.