Regulatory Affiars Executive at AMN Life Science Private Limited · Kanakia Zillion, Mumbai · 3 - 6 years · ₹2.5L - ₹6L / yr · Profitable · Posted 25 May 2021

JOB DESCRIPTION:
- Dossier preparation, review submission in ACTD/ CTD/ Country Specific format for Product registration for local and export to ensure error free timely submissions as per marketing Dept. timeline.
- To evaluate respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query. Ensure accurate and timely responses to queries.
- Review technical documents like process validation, AMV, Stability and composition etc, labeling, batch records, specification sheets or test methods for compliance with applicable regulations and policies.
- To Co-ordinate / to visit with respective dept. in HO / Plant / ADL / R D for documents samples required for dossier / registration purpose. Co-ordination with API / PM vendors to resolve technical quires w.r.t. regulatory requirements.
- Artwork Checking development for registration and commercial purpose as per regulatory requirement Ensure that all product artwork is updated when necessary and submitted in correct format and subsequent approved artwork is accurately recorded and communicated. Handling local FDA, DCGI and regulatory related activities.
- Ensuring accurate recording and communication of regulatory submissions, correspondence with authorities and final approval to facilitate compliance.
- Carrying out any task delegated by Export Manager which contributes to overall running of the Export Department and assisting Export Manager in marketing business development activities. Participate in training activities for career development to attain a high level of competency in all aspects of regulatory affairs. Maintain current knowledge base of existing and emerging regulations, standards or guidance documents.

Similar jobs (10)
Job Title : Oracle Analytics Cloud (OAC) / Fusion Data Intelligence (FDI) Specialist
Experience : 3 to 8 years
Location : All USI locations – Hyderabad, Bengaluru, Mumbai, Gurugram (preferred) and Pune, Chennai, Kolkata
Work Mode : Hybrid Only (2-3 days from office or all 5 days from office)
Mandatory Skills : Oracle Analytics Cloud (OAC), Fusion Data Intelligence (FDI), RPD, OAC Reports, Data Visualizations, SQL, PL/SQL, Oracle Databases, ODI, Oracle Cloud Infrastructure (OCI), DevOps tools, Agile methodology.
Key Responsibilities :
- Design, develop, and maintain solutions using Oracle Analytics Cloud (OAC).
- Build and optimize complex RPD models, OAC reports, and data visualizations.
- Utilize SQL and PL/SQL for data querying and performance optimization.
- Develop and manage applications hosted on Oracle Cloud Infrastructure (OCI).
- Support Oracle Cloud migrations, OBIEE upgrades, and integration projects.
- Collaborate with teams using the ODI (Oracle Data Integrator) tool for ETL processes.
- Implement cloud scripting using CURL for Oracle Cloud automation.
- Contribute to the design and implementation of Business Continuity and Disaster Recovery strategies for cloud applications.
- Participate in Agile development processes and DevOps practices including CI/CD and deployment orchestration.
Required Skills :
- Strong hands-on expertise in Oracle Analytics Cloud (OAC) and/or Fusion Data Intelligence (FDI).
- Deep understanding of data modeling, reporting, and visualization techniques.
- Proficiency in SQL, PL/SQL, and relational databases on Oracle.
- Familiarity with DevOps tools, version control, and deployment automation.
- Working knowledge of Oracle Cloud services, scripting, and monitoring.
Good to Have :
- Prior experience in OBIEE to OAC migrations.
- Exposure to data security models and cloud performance tuning.
- Certification in Oracle Cloud-related technologies.
Job Overview:
To generate revenue by selling telecommunications services and products to businesses and individuals, including mobile, internet, voice, and data solutions. The role involves building and maintaining strong customer relationships, meeting sales targets, and providing excellent customer service.
Job Description*
* Exceptional communication skills to provide support to customers & team members if and when required.
* Ability to lead a customer through the sales process, determining needs, and closing the sale.
* Strong foundational knowledge in information technology on data and voice solutions from telco service providers.
* Worked on solutions like MPLS, SD-WAN, SIP (Voice), Cloud Telephony, Data Centre, Mobility SIM Card, Cloud solutions (Azure/ AWS).
* Strong Interpersonal skills to liaise with other departments and people within the organization.
* Strong C level connects in the SME & Mid-market segment within the defined geography.
* Ability to lead by example and act with integrity.
* Min experience of 3 years Plus in hardcore IT sales & Telecommunication is mandatory.
Qualifications:
*Education: Bachelor's degree in Business, Marketing, Telecommunications, or a related field.
Experience in telecom sales, B2B/B2C sales, or a related field.
Skills:
* Strong communication, negotiation, and interpersonal skills.
* Ability to build relationships and handle objections.
* Knowledge of telecom products and services (mobile, internet, broadband, ILL, MPLS, PRI, SD Wan, Sip Trunk, etc.).
* Goal-oriented with a proven ability to achieve sales targets.
* Problem-solving skills and a customer-focused approach.
Benefits:
• Career Growth Opportunities: Emphasis on continuous learning, internal promotions, and opportunities for upward mobility within the organization.
• Performance-based Incentives: Bonuses, rewards, or recognition programs tied to meeting or exceeding performance goals.
• Professional Development: Access to training programs, certifications, and workshops to enhance skills and competencies.
Job Description:
Responsibilities:
· Participate in the entire application lifecycle, focusing on coding and debugging
· Ability to design and document the product features, codes.
· Self-driven and ability to take up ownership of things
· Write clean code to develop functional applications, automation scripts, test cases
· Troubleshoot and debug applications
· Collaborate with developers, cross-functional teams to identify issue, new features and come up with solutions
· Gather and address technical and design requirements
· Provide training and support to internal teams
· Build reusable code and libraries for future use
· Ability to sync with other developers, designers to identify issues, new features and improvements
Requirements and skills:
· Solid understanding of linux development environment and systems
· Expert level knowledge of Python along with frameworks like Django, flask
· Proficient in writing unit test cases using Pytest framework.
· Expert level knowledge of SQL databases like MySQL and PostgreSQL
· Good knowledge of design principles and databases
· Knowledge of front technologies like Typescript, ReactJs
· Knowledge of Caching techniques using Memcached and Redis
· Experience of using queueing service line Kafka
· Solid understanding of microservices architecture
· Knowledge of AWS cloud services
· Expert in serverless technologies like lambda along with API gateway
· Knowledge of Git, Jira, CI/CD pipelines and containerization like docker
· Knowledge of logging and monitoring tools like Grafana or Newrelic
POST - SENIOR DATA ENGINEER WITH AWS
Experience : 5 years
Must-have:
• Highly skilled in Python and PySpark
• Have expertise in writing Glue jobs ETL script, AWS
• Experience in working with Kafka
• Extensive SQL DB experience – Postgres
Good-to-have:
• Experience in working with data analytics and modelling
• Hands on Experience of PowerBI visualization tool
• Knowledge and hands-on on version control system - Git Common:
• Excellent communication and presentation skills (written and verbal) to all levels
of an organization
• Should be results oriented with ability to prioritize and drive multiple initiatives to
complete work you're doing on time
• Proven ability to influence a diverse geographically dispersed group of
individuals to facilitate, moderate, and influence productive design and implementation
discussions driving towards results
Shifts - Flexible ( might have to work as per US Shift timings for meetings ).
Employment Type - Any
AD Skills:
- Implementing Active Directory Infrastructure
- Expertise on Windows Infrastructure components integration like DNS, DHCP etc.
- Assess Domain Controllers, Domain Architecture, Centralized Migrations, GPO Designs, Windows DNS/DHCP Management and Forest Level Trust Architecture
- Cloud Service integration with Active Directory including Amazon Web Services and Azure Active Directory Services
- Multi Forest/Domain Active Directory and DNS migration
- In depth knowledge of AD Site Topology, OU’s Structure, Group Policies, NTP, LDAP and implementation and AD components
- Good knowledge on AD Security and identity principals
- Strong integration experience of ADFS and integration with the on-prem Active Directory
- As a Pre-Sales Engineer, you will be responsible for designing and drafting systems for Technical Proposals brought in by the sales team, ensuring that quotes are technically correct before submitting to clients.
- Preparation of proposal based on the RFP / RFQ docs and Understand the CAD drawing.
- Generate BOQ, Compliance Statement, system descriptions, schematic drawings, material / technical submittal, system programming such as Crestron, Extron, Bose and other OEM products etc.
- Provide sales and technical staff with technical support on both a pre- and post-sales basis
- Communicate and interact with internal employees, clients and colleagues in a professional and timely manner.
- Conduct or attend a Site visit and Site surveys when needed.
- Develop and maintain knowledge of current and new technologies that company offers.
We are a nascent quantitative hedge fund led by an MIT PhD and Math Olympiad medallist, offering opportunities to grow with us as we build out the team. Our fund has world class investors and big data experts as part of the GP, top-notch ML experts as advisers to the fund, plus has equity funding to grow the team, license data and scale the data processing.
We are interested in researching and taking in live a variety of quantitative strategies based on historic and live market data, alternative datasets, social media data (both audio and video) and stock fundamental data.
You would join, and, if qualified, lead a growing team of data scientists and researchers, and be responsible for a complete lifecycle of quantitative strategy implementation and trading.
Requirements:
- Atleast 3 years of relevant ML experience
- Graduation date : 2018 and earlier
- 3-5 years of experience in high level Python programming.
- Master Degree (or Phd) in quantitative disciplines such as Statistics, Mathematics, Physics, Computer Science in top universities.
- Good knowledge of applied and theoretical statistics, linear algebra and machine learning techniques.
- Ability to leverage financial and statistical insights to research, explore and harness a large collection of quantitative strategies and financial datasets in order to build strong predictive models.
- Should take ownership for the research, design, development and implementation of the strategy development and effectively communicate with other team mates
- Prior experience and good knowledge of lifecycle and pitfalls of algorithmic strategy development and modelling.
- Good practical knowledge in understanding financial statements, value investing, portfolio and risk management techniques.
- A proven ability to lead and drive innovation to solve challenges and road blocks in project completion.
- A valid Github profile with some activity in it
Bonus to have:
- Experience in storing and retrieving data from large and complex time series databases
- Very good practical knowledge on time-series modelling and forecasting (ARIMA, ARCH and Stochastic modelling)
- Prior experience in optimizing and back testing quantitative strategies, doing return and risk attribution, feature/factor evaluation.
- Knowledge of AWS/Cloud ecosystem is an added plus (EC2s, Lambda, EKS, Sagemaker etc.)
- Knowledge of REST APIs and data extracting and cleaning techniques
- Good to have experience in Pyspark or any other big data programming/parallel computing
- Familiarity with derivatives, knowledge in multiple asset classes along with Equities.
- Any progress towards CFA or FRM is a bonus
- Average tenure of atleast 1.5 years in a company










