BSc Life Sciences Associate Publishing at MakroCare – Apply Online
Associate – RA Publishing
Hyderabad, Telangana, India
About the job
Position: Associate – RA Publishing
Location: Hyderabad, Madhapur, Telangana – 500081
Experience Required: 1-3 Years
Education: Bachelor’s Degree in Life Sciences or related field
Markets: US/UK/EU/ROW
Job Summary
- We are seeking a detail-oriented and proactive Associate – Regulatory Affairs (RA)
- Publishing with 1-3 years of experience in regulatory submissions across global markets including the US, UK, EU, and ROW (Rest of World). The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions. This role is crucial for facilitating on-time submissions, executing submission build activities, and ensuring compliance with regulatory requirements.
Key Responsibilities
- Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets including the US, UK, EU, and ROW.
- Ensure submissions are compliant with the regulatory guidelines and are ready for on-time dispatch.
- Manage and track the status of submissions and respond to regulatory agencies’ queries promptly and accurately.
- Prepare and review key regulatory documents including Master Formula Card (MFC),
- Batch Manufacturing Record (BMR), Stability Protocols/Reports, Sampling Protocols, and
- Process Validation Protocols/Reports.
- Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documentation.
- Conduct thorough quality checks and validations on compiled submissions to ensure they meet all regulatory and internal quality standards.
- Create inter-document links, and manage the integrity and accuracy of submission components.
- Execute submission build activities, including the generation and validation of final submission outputs.
- Manage the submission lifecycle, ensuring compliance with timelines and regulatory requirements.
- Support the publishing tasks, including the management of electronic and paper submissions.
- Facilitate communication with regulatory authorities to resolve queries and provide additional documentation as required.
- Assist in the preparation and submission of responses to regulatory agencies in a timely manner.
- Identify opportunities for process improvements in submission preparation and publishing.
- Stay updated with the latest regulatory requirements and best practices in submission management.
Skills & Competencies
- Proficient in eCTD/aCTD submission management.
- Strong knowledge of global regulatory guidelines (US, UK, EU, ROW).
- Experience in preparing and reviewing regulatory documents such as MFC, BMR,
- Stability Protocols/Reports, Sampling Protocols, Process Validation Protocols/Reports, and PDR.
- Excellent attention to detail with strong organizational and project management skills.
- Ability to work effectively in a team-oriented environment with cross-functional teams.
- Strong communication skills, both written and verbal.
- Proficient in MS Office Suite and regulatory publishing tools.
- Ability to manage multiple projects and prioritize tasks effectively.
Preferred Qualifications
- Experience in regulatory affairs publishing within the pharmaceutical/biotechnology industry.
- Familiarity with regulatory submission tools and databases.
- Knowledge of current global regulatory submission requirements and trends.
How To Apply
Interested candidates should submit their resume and a cover letter to [email protected] with the subject line “Application for Associate – RA Publishing.”
Skills: publishing, ROW, documentation, regulatory affairs, electronic common technical document (eCTD), regulatory submissions, European affairs
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