Job Role: Clinical Trial Regulatory Manager
Department: Pharma Regulatory
Job Location: Bangalore
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
Role Accountabilities
- Preparation, review, and amendments of required regulatory documents and / information for submission to regulatory authorities for Phase I-IV clinical trials, Bioavailability and Bioequivalence studies for export purposes, CT-16 and Form 12 applications [Import Licenses, Test Licenses] as per departmental SOPs.
- Coordinating with the interfacing departments for procuring appropriate information for submission to regulatory authorities and obtaining application fee for conducting clinical trials and BA/BE studies from the concerned departments and / Sponsor wherever applicable.
- Providing regulator/timely updates on approval to internal and external stakeholders through emails/Team's call.
- Submission of subsequent protocol amendments, clinical trial reports, annual status reports and any study related information to the regulatory authorities.
- Registration of clinical trials with Clinical Trial Registry – India (CTRI) wherever applicable.
- Notification of Serious Adverse Events to the regulatory authorities.
- Archival of approvals, licenses, study dossiers appropriately in the regulatory affairs department.
- Development of departmental SOPs and periodic revisions and training of RA personnel and stakeholders on same.
- Impart training to the RA personnel / stake holders on SOPs, regulations, and functions of RA department after being designated by Head-RA.
- Coordinating with the shipping service provider for handover and retrieval of the original licenses.
- Tracking and monitoring of regulatory environment, sharing policy updates with the Regulatory Team and internal stakeholders as appropriate
- Carry out other activities that may be assigned from time to time by the Head-RA.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Experience & Qualifications:
- M Pharm / M Tech Biotech / Masters in related field from a reputed University
- Strong working experience background in Regulatory Affairs with hands-on experience in handling of Clinical trial / BA BE application submissions to CDSCO
- Working knowledge of SUGAM portal / NSWS portal
- Good understanding of New Drugs & Clinical Trials Regulations 2019
- Working knowledge of Microsoft / AI tools
- Good communication skills
- Collaborative & self-driven individuals will be given preference
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.
