Job
Description
About Syngene: Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything you do personally and professionally. Safety is placed at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs in letter and spirit. It is mandatory for all roles at Syngene to adhere to safe practices and procedures, contributing to the development of procedures, practices, and systems that ensure safe operations and compliance to the company's integrity and quality standards. A corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline is to be driven at the workplace at all times. Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following EHS requirements is essential. Completing all assigned mandatory trainings related to data integrity, health, and safety measures on time by all team members, including self, is a requirement. Compliance with Syngene's quality standards and holding self and teams accountable for safety goals are crucial. Core Purpose of the Role: Responsible for overseeing the Regulatory Affairs function across Biocon Park, MN Park Hyderabad & MSEZ Mangalore facilities. The role ensures compliance with National regulations, supports strategic initiatives, and fosters Syngene's position as a trusted partner for clients and regulators. Role Accountabilities: - Develop and execute a forward-looking, risk-based regulatory strategy aligned with Syngene's business priorities. - Drive long-term relationships with regulators, advocating for policies that enable sustainable growth. - Identify and address inefficiencies in cross-business processes to strengthen regulatory operations. - Represent Syngene in regulatory inspections and audits, ensuring preparedness and successful outcomes. - Build and mentor a high-performing regulatory team with capabilities aligned to future needs. - Offer innovative solutions that align with both client and organizational goals. - Drive change management efforts that enhance cross-functional collaboration and operational excellence. Primary Responsibilities: - Develop and execute a risk-based regulatory strategy to mitigate compliance risks while supporting business goals. - Lead the development and implementation of regulatory policies, ensuring alignment with national standards and organizational objectives. - Proactively identify changes in regulatory landscapes and prepare the organization for future requirements. - Provide strategic guidance to project management and operations teams on regulatory planning and submissions. - Strategize and coordinate prompt submission of regulatory applications across sites & represent Syngene during regulatory inspections and audits, ensuring successful outcomes. - Provide consultation to internal stakeholders regarding national regulatory aspects as and when needed. - Implement and maintain processes, procedures, and trackers essential for national regulatory support function performance in the organization. - Provide prompt updates to stakeholders on licenses/permissions and participate in teleconferences/discussions with stakeholders/clients as required. - Train and mentor regulatory team members and stakeholders on compliance requirements, fostering a culture of excellence and continuous improvement. - Proactively anticipate changes in the regulatory landscape, developing strategies to address future requirements while safeguarding compliance. - Lead policy advocacy efforts, engaging with industry associations and regulatory authorities to represent Syngene's interests effectively. Leadership Capabilities: - Excellent English and Kannada language skills, both verbal and written. - Excellent communication skills. - Client Relationship Management, Team building, and leadership. - Analytical and reasoning skills. - Excellent awareness of regulatory requirements in the country. Syngene Values: All employees will consistently demonstrate alignment with our core values: - Excellence - Integrity - Professionalism Specific Requirements for this Role: Experience: 18+ years in regulatory affairs with proven success in leading teams and managing high-stakes regulatory challenges. Education: Advanced degree (masters or higher) in Pharmacy, Biological Sciences, or related fields. Certifications in Regulatory Affairs are highly desirable. Skills and Capabilities: 1. Reviewed submissions made to the regulators relating to import, export, development (R&D), manufacture, clinical development, post-approval changes, storage, disposal of drug substances and drug products (human and animal). 2. Other associated approvals, namely: biosafety, recombinant, narcotics, atomic energy related, agrochemical related, animal husbandry related, FSSAI related, and any other approvals as relevant. Equal Opportunity Employer.,
