Job Description

JOB DESCRIPTION

Job Title: Asst Manager-Regulatory

Job Location: Bengaluru

Reporting to: Deputy GM

Job Grade: 8-II

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 we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company\'s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene\' s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Role Accountabilities:

Responsible for assisting in National Regulatory Affairs function in Syngene International Limited, Biocon Park, MN Park Hyderabad & MSEZ Mangalore facilities for:

a) Approvals related to import, development, manufacture, storage and export of drug substance and drug product (human and animal), as well as,

b) Other associated approvals, namely: biosafety, recombinant, narcotics, atomic energy related, agriculture related, animal husbandry related, food related, and any other approvals as relevant.

Primary Responsibilities:

• Providing consultation to the stakeholders and clients regarding national regulatory aspects, as and when required.
• Implementing and maintaining process, procedures, and trackers that are essential for national regulatory support function performance in the organization.
• Identifying the regulatory requirements.
• Interacting with the regulators and coordinating their inspections/ visits to Syngene.
• Coordinating with stakeholders and ensuring successful inspection at Syngene.
• Providing time to time update to the stakeholders on the licences and participating in teleconferences/discussions with stakeholders / clients as required.
• To train / bring awareness to stakeholders with respect to regulatory requirements. To train regulatory team members in relevant national regulatory support activities.
• Planning and execution of the regulatory activities with regulators and for internal stake holders.

Secondary Responsibilities:

• Support Business Development and the Management in the Request for Proposals and any business queries related to National Regulatory requirement.
• Supporting Program management in planning and tracking the National regulatory support activity.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

• Experience: 9-12 years
• Demonstrated Capability:

• Analysis of rules and regulations of drugs and its accurate application in regulatory function.
• Maintaining regulatory trackers and alert mechanism.
• Understating of regulatory queries and suggest appropriate response to the regulator.
• Education: B.Pharm

Skills and Capabilities:

• Excellent English fluency skills, both verbal and written.
• Strategic Planning & Execution Corporate Liaison and Affairs.
• Regulatory Compliance (Inspection, Approvals & Licenses).
• Client Relationship Management Team building and leadership.

Syngene International