Associate I

2 days ago

Chennai, India Pfizer Full time

Role Summary
- Support Product Leads develop CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting PBG products registered and marketed within the Asia Pacific (APAC) or Africa and Middle East (AfME) or European Union (EU) region, with supervision.
- Provide operational global CMC regulatory support and documentation for assigned projects/products covering initial registrations and approval/post approval activities of Low and medium complexity/risk. Assembles CMC information for submission to APAC or AfME or EU region regulatory agencies and supports CMC strategies with supervision. Maintains and tracks submission and approval statuses. Perform regulatory fact finding for the preparation of CMC information for submission to global regulatory agencies.Maintain CMC systems and perform data entry.
- Assist cross-functional project teams by scheduling meetings, taking notes and tracking action items independently.
- Opportunity to increase level of complexity and independence with potential career path of CMC Product Lead.

Role Responsibilities
- Works under direct supervision under Team Lead/Designee and manages projects and executes the agreed upon strategies and plans. Supports team in the development of regulatory strategies to support registrations.
- Responsible for authoring CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control of low to minor complexity with appropriate supervision.
- Makes decisions to resolve minor problems in standard situations. Makes decisions within guidelines and policies.
- Understands the fundamental business drivers for the company. Uses this knowledge in own work.
- Ability to develop projects plans to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.

**Qualifications**:

- Postgraduate in Pharmacy or equivalent Sciences degree.
- Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE

  • Associate Level I

    2 days ago

    Chennai, India BNP Paribas Full time

    ASSOCIATE LEVEL I (JOB NUMBER: MFS000497) **Direct Responsibilities** - Keep up and manage every operational aspects linked to the activity of US AGL team. (Collateral booking and returns) - Ensure settlement of collateral trades. Monitor all the collateral trades are settled on time in adherence to the settlement cycle. - Understanding the importance of our...

  • Associate, Accounting Representative I

    4 days ago

    Chennai, Tamil Nadu, India BNY Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Associate, Accounting Representative IAt BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of the world's investible assets. Every day, our teams harness cutting-edge AI and breakthrough...

  • Associate, Accounting Representative I

    5 days ago

    Chennai, Tamil Nadu, India BNY External Career Site Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Associate, Accounting Representative IAt BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of the world's investible assets. Every day, our teams harness cutting-edge AI and breakthrough...

  • Associate Level I

    2 days ago

    Chennai, India BNP Paribas Full time

    **Job Description - APAC** Job Title: Associate Level I Date: Department: Global settlements **Location**: Chennai Business Line / Function: BSO Reports to: (Direct) Assistant manager Grade: (if applicable) (Functional) Number of Direct Reports: Directorship / Registration: **Position Purpose**: Facilitating transaction processing of instructions...

  • Position of Project Associate-i

    2 weeks ago

    Madhavaram, Chennai, Tamil Nadu, India Tamil Nadu Veterinary and Animal Sciences University Full time

    **TAMIL NADU VETERINARY AND** **ANIMAL SCIENCES UNIVERSITY** Veterinary College and Research Institute Namakkal - 637 002, Tamil Nadu Notification Number: 459 / ANN / SFS-FFT/VCRI / NKL / 2024 Date: 25.10.2024. **WALK IN INTERVIEW FOR THE POSITION OF PROJECT ASSOCIATE-I** A walk-in interview for the position of **Project Associate - I** (One Post) under...

  • Associate, Middle Office I

    6 days ago

    Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full time

    Associate, Middle Office I At BNY, our culture allows us to run our company better and enables employees’ growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of the world’s investible assets. Every day, our teams harness cutting-edge AI and breakthrough technologies to...

  • Associate, Client Processing Representative I

    1 week ago

    Chennai, Tamil Nadu, India BNY External Career Site Full time

    Associate, Cash Processing/Funds Transfer IAt BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of the world's investible assets. Every day, our teams harness cutting-edge AI and breakthrough...

  • Associate, Corporate Actions I

    2 weeks ago

    Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full time

    **Associate, Corporate Action I** At BNY, our culture allows us to run our company better and enables employees’ growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of the world’s investible assets. Every day, our teams harness cutting-edge AI and breakthrough...

  • Associate, Middle Office I

    2 weeks ago

    Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full time

    **Associate, Middle Office I** At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions with...

  • Associate, Middle Office I

    2 weeks ago

    Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full time

    ASSOCIATE, MIDDLE OFFICE I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create solutions with...