Manager, Regulatory Operations

POSITION OVERVIEW:

As a Regulatory Operations Manager, you will play a pivotal role in overseeing and managing regulatory operations and consultants. This position requires a strategic focus on guiding IND and NDA filings, and contributing to business development efforts through client interactions and proposal support.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Manage systematic submissions for regulatory documents, ensuring compliance with FDA guidelines and validation requirements.
• Conduct client meetings to update on responsibilities and project status.
• Independently coordinate components of regulatory submissions.
• Handle multiple client projects simultaneously, addressing unplanned submissions and urgent FDA requests.
• Format documents to meet FDA electronic submission standards and conduct quality control checks for accuracy.
• Maintains responsibility for the planning, timelines and production of large complex FDA submissions.
• Conducts and/or participates in final review of published submissions to ensure compliance to requirements.
• Lead the regulatory operations team, ensuring client-facing roles align with business goals.
• Communicates Leadership Team decisions, initiatives, and activities to Managers, Regulatory Operations, as appropriate.
• Final review authority ensures regulatory submissions are published while maintaining compliance and quality according to internal or external timelines.
• Understand, interprets and consults on regulatory eCTD submissions.
• Train/coach team members in submission publishing techniques and processes.
• Provide mentorship and management to team members, ensuring optimal utilization and effective leadership.
• Maintain a calm demeanor under pressure, leveraging deep knowledge of international regulatory requirements.
• Strong leadership, communication, and presentation skills, with a comprehensive understanding of drug development and regulatory compliance.
• Emphasis on teamwork, collaboration, and enhancing project coordination and communication.
• Resource allocation across team including routine meetings, development and recruiting needs.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s or Master’s degree in Pharmacy, Biological Sciences, Engineering, or a related field. Advanced degree preferred

Experience:

• Minimum 10+ years of experience in regulatory operations publishing in biotech or pharma.
• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.
• Expertise in software tools and processes used in regulatory submissions; adept at integrating different systems and adapting to client-specific software.
• Expertise in formatting and publishing tools, adept at utilizing Adobe and Microsoft Office add-ins.
• Strong attention to detail crucial for error-free document preparation and validation.
• Effective communication skills, both verbal and written, essential for team collaboration and client interactions.
• Flexible and able to adapt to handle regulatory updates and varying project demands. Emphasis on teamwork and collaboration, improving communication, and enhancing project coordination.
• Broad software proficiency; strong knowledge of MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, eCTD Publishing Software, and Electronic Document Management Systems.

Skills and Attributes:

• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Ability to manage multiple priorities and work independently in a fast-paced environment
• Proactive, detail-oriented, and self-motivated with a strong work ethic