Pharma Regulatory

Location: Bangalore, India

JOB DESCRIPTION

Job Title: Pharma Regulatory

Job Location: Syngene International Limited, Bengaluru

About Syngene: Syngene ( www.syngeneintl.com ) 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

Core Purpose of the Role: To assist pharma regulatory team of Syngene in executing submissions for various licensing activities and follow up with regulators to ensure timely approvals.

Role Accountabilities :

• Preparation and submission of CT-10, CT-12, CT-13, CT-16, Form 12 applications to CDSCO (biological and small molecules), Export NOC, Form 29, GMP, WHO-GMP, license retention, Form 37, COPP, WC and endorsement applications to CDSCO and SLA as applicable.

• Respond to regulator’s queries by collaborating with internal and external stakeholders.

• Follow-ups for approvals with CDSCO, Zone, SLA and NCB.

• Filling quarterly returns to NCB and maintain compliance to RCS, 2013.

• Supporting the team in preparation of IBSC and RCGM application, coordinate and convene IBSC meetings on behalf of member secretary, IBSC.

• Providing consultation to the internal stakeholders and clients regarding national regulatory requirements as and when required.

• Maintenance of all submissions and approvals record by maintaining database and trackers.

Manufacturing licenses (R&D and commercial), import and export permissions, liaising with State regulators.

• Providing time to time update to the stakeholders on the licenses and participating in teleconferences/ discussions with stakeholders / clients as required.

• Prepare new SOPs as and when required, update current SOPs periodically.

• Keep all operating units updated on recent change in rules and regulations governing product development life cycle.

Leadership Capabilities:

• Maintain a culture of collaboration and team building in the department.

• Foster behavior for continuous learning and development

• Clear and precise communication while collaborating with stakeholders.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence

• Integrity

• Professionalism

Specific requirements for this role

• Experience

• Demonstrated Capability

• Education

• Experience: Experience: 7-8 years

Skills and Capabilities

• Able to make error free submissions and ensure timely approvals.

• Attention to detail

• Time management

• Education M.Pharma

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.