Title:  Team member, Regulatory Affairs

JOB DESCRIPTION

Job Title: Junior Manager - Regulatory Affairs

Job Location: Syngene International Limited, Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)

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:

The candidate will combine his/her knowledge of scientific & regulatory guidelines, CMC regulatory and filing skills to ensure successful filing, registrations, and post-approval maintenance for the intended countries. The candidate will lead eCTD filing, Regulatory DMS and QMS system activities.

Role Accountabilities

The candidate’s contribution will help bring the much-needed therapeutics to the unmet need of the patients, thereby positively impacting mankind. The candidate will be accountable for:

• Pivotal CMC Regulatory support throughout the development cycle of the novel drugs space and generics space, including small molecule & biologics, in marketing authorization / DMF filing and lifecycle management, predominantly for Developed countries and for certain Emerging countries, based on the market requirement.
• Research on regulatory requirements for new molecules / category of products based on business need in time-bound manner and provide feasibility/technical inputs to the team.
• Identify requirements for IND, NDA, MAA, ANDA, ANADA and other Dossiers, prepare checklists, ensuring regulatory compliance.
• Interact with stakeholders, collate necessary document, Review plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc, conduct thorough regulatory assessment, identify risks, communicate to team and client, and recommend corrective measures.
• Plan and develop sections, compile, author, and Publish eCTD Dossiers. Ensure timely submission. Respond to regulatory agencies on a timely basis. Responsible for Regulatory project management.
• Provide Regulatory strategy inputs to the team and the clients. Assessing the regulatory requirements for various business requirements as and when needed.
• Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers/DMFs as required to meet changes in internal systems, changes in regulatory guidelines.
• Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists, and review New Quality Agreements.
• Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures imparted by the company.
• Traveling to other sites within Karnataka if necessary, though travel requirements are minimal.

Leadership Capabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience
2. Demonstrated Capability
3. Education

Experience

• Must have experience of 6 to 13 years in CMC Regulatory Affairs for small molecule API / Formulations (preferably in injectables) for US/Europe/Developed Markets
• Must have hands-on experience in investigational medicinal products and marketing authorization.
• Experience in Biologicals /ADC / veterinary drugs is a definite plus.

Skills and Capabilities

• High-level English Proficiency in reading, writing, and communication
• Hands-on Experience in eCTD. Experience in RDMS, EDMS & QMS is definite plus.
• Thorough understanding of CMC (API & Drug Product) and skill in regulatory interpretations and application

Education

• B.Pharm / M. Pharm / Life sciences degree with minimum 5 + years of working experience with Pharmaceutical / Life science. 

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.