Manager, Regulatory Operations

Job Description Company Description A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious Best Places to Work 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com 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. Education QUALIFICATIONS AND REQUIREMENTS: - 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 Legal Statement Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.