Associate - Regulatory Affairs (Publishing)

3 days ago

Hyderabad, Telangana, India Makrocare Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Education: Bachelors 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.

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