Associate I

1 month 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

  • Project Associate-i

    1 month ago

    Guindy, Chennai, Tamil Nadu, India University of Madras Full time

    Applications are invited for the position of Project Associate-I (one post) to work on SERB-EEQ Sponsored research project entitled **“Development of Rhamnolipid and Sophorolipid Encapsulated Metal Oxide Nanoparticles and Their Biodegradable Polymer Nanocomposites: Toxicity Assessment on Food borne Pathogens, Preservatives and Food Packaging...

  • Associate Level I

    3 days ago

    Chennai, India BNP Paribas Full time

    ASSOCIATE LEVEL I (JOB NUMBER: BUS000881) **Direct Responsibilities** Develop & maintain all BCP related documentation Propose functional and technical recovery solutions, to be validated by the management of the entity and/or BCP Committee Ensure that members of staff are adequately trained for BCP. Roll out an awareness program Be an active member of...

  • Data Entry Associate I

    7 days ago

    Chennai, India VARITE INDIA PRIVATE LIMITED Full time

    Description: Location: Chennai/Hyderabad Exp: Fresher to 1 Year Shift:7 AM-5 PM IST /10 AM-7 PM IST /5 PM-2 AM IST ( Rotational shifts) Role:Data Entry Associate I - Excellent written and verbal communication with no MTI - Interview process 1st round might be an assessment and 2nd round might be in person interview (F2F) which is yet to get confirmation...

  • Associate Level I

    1 week 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...

  • Associate I

    2 months ago

    Chennai, India Pfizer Full time

    The LOM, Associate I will provide operational support for project tasks including: - Generate necessary renditions in GDMS (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate. - Facilitate workflow through corporate document repository, e.g., GDMS. - Finalize documents post QC (including update of GDMS document...

  • Associate, Proposal Development I

    3 weeks ago

    chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Proposal Development I Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...

  • Associate, Payroll Administration I

    3 weeks ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Payroll Administration I-APAC Payroll Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as...

  • Associate, Payroll Administration I

    3 weeks ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Payroll Administration I-APAC Payroll Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as...

  • Associate, Client Processing I

    6 days ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Client Processing I Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...

  • Associate, Client Service I

    3 weeks ago

    Chennai, India BNY Mellon Full time

    Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - 97% of the world’s top banks...

  • Associate, Client Service I

    2 weeks ago

    Chennai, India BNY Mellon Full time

    Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - 97% of the world’s top banks...

  • Associate, Credit Risk I

    2 days ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview 53012 - Associate, Credit Risk I Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...

  • Associate, Digital Marketing I

    2 days ago

    Chennai, India BNY Mellon Full time

    Overview Associate, Marketing - Digital Marketing I - #44237 Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known...

  • Associate, Corporate Actions I

    6 days ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate I, Corporate Actions Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...

  • Associate, Compliance

    3 weeks ago

    chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    BNY Mellon Global Job Posting Template Updated: Jan. , – W. Wilber    Associate, Compliance & Control Representative I Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that...

  • Associate, Compliance

    3 weeks ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    BNY Mellon Global Job Posting Template Updated: Jan. , – W. Wilber    Associate, Compliance & Control Representative I Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that...

  • Associate, Compliance

    2 weeks ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Compliance & Control I Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...

  • Associate, Corporate Actions I

    3 weeks ago

    Chennai, India BNY Mellon Full time

    Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - 97% of the world’s top banks...

  • Associate, Payroll Administration I

    2 weeks ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Payroll Administration I-APAC Payroll Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as...

  • Associate, Client Service Representative I

    3 weeks ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Client Service Representative I Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...