Job description

KEY RESPONSIBILITIES:

• Executes regulatory activities for team members or projects in accordance with applicable regulations and guidelines, under supervision.

• Prepares, reviews and releases routine submissions to INDs such as investigator updates, safety reports, annual reports and IND amendments, under supervision. Prepares submission cover letters and forms.
• Researches and assists in the preparation of general responses to FDA queries.

• Attends study team meetings and provides guidance on regulatory administrative and logistical issues.
• Assists with Agency meetings.
• Knowledgeable of submission requirements and completes Document Plans for regulatory submissions. Works with Regulatory Operations to ensure documents are in system; performs QC checks on published submissions to ensure completeness and compliance with company guidelines and FDA regulatory requirements.
• Schedules and manages meetings, accurately captures scientific discussion in minutes.

SKILLS REQUIRED:

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 5 to 10 years pharmaceutical/biopharma Regulatory experience including experience as an with international experience strongly preferred.
• Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
• Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.

• Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
• Good judgement in elevating and communicating actual or potential issues to line management.
• Excellent written and oral communication skills.
• Experience of active participation in Agency/Industry groups/forums expected.
• Flair for regulatory strategy

Job Types: Full-time, Contract, Temporary

Pay: $52,150.40 - $100,813.84 per year

Benefits:

• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• Regulatory Affairs: 5 years (Required)

Language:

• Japanese (Required)

Work Location: Remote

Speak with the employer
+91 +15515544366

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