Associate - Ra Publishing

7 days ago


Hyderabad Telangana, India Makrocare Full time

**Job Summary**:
**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.

**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.



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