![Pfizer](https://media.trabajo.org/img/noimg.jpg)
Associate Ii
3 weeks ago
Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post
- approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities include the following, but not limited to:
- Ensures effective coordination and collaboration with GRS-CMCs and the regional regulatory leads to ensure key submission deliverables for the assigned projects to the team.
- Responsible for end to end CMC contribution for the assigned projects; Reviews the assigned regulatory activities including the related technical/supportive information/ documents for completeness and accuracy; Responsible for development of initial global regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC; Responsible for authoring and/or compiling Regulatory Strategy Documents (RSD) where needed; Responsible for authoring of CMC content in Module 1, Module 2.3, M3.2.S/P/R as agreed upon with the GRS CMC within agreed timelines.
- Responsible for identification and communication of identified risks to the GRS CMCs and/or appropriate leadership, also proposes mitigation strategy with the support of team lead; Ensures resolution of issues and manages regulatory risks within project.
- Reviews and applies pertinent global regulatory guidelines. Exhibits technical / functional expertise and provides strategies on regulatory requirement, negotiates with and influences the cross functional teams, colleagues and external partners to ensure regulatory data requirements are met.
- Coordinates with the respective team for M3.2.R Ancillary documents.
- Represents HBU GRA CMC point of view and meets with key stakeholders to resolve challenges.
- Coordinates internal document review and sign off.
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.
- Supports Query and/or commitment management in collaboration with GRS CMCs.
- Maintains conformance systems maintenance in support of the GRS CMCs.
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, Control Ii
2 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate, Control II 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” -...
-
Associate, Control Ii
3 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full time**Overview** **Associate, Control II** **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, Control Ii
2 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full time**Overview** **Associate, Control II** **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 Processing Ii
3 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate, Client Processing II 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 Processing Ii
2 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full time**Overview** Associate, Client Processing II **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...
-
Associate, Business Technology Liaison Ii
3 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate, Quality Engineer II 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 Ii
7 days ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate, Digital Marketing II 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, Business Technology Liaison Ii
3 weeks ago
Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full time**Associate, Quality Engineer II** **_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, Valuations/pricing Representative Ii
2 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate, Valuations/Pricing Representative II 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, Valuations/pricing Representative Ii
2 weeks ago
Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full timeAssociate, Valuations/Pricing Representative II **_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, Cash Processing/funds Transfer Ii
7 days ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate, Cash Processing/Funds Transfer II 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...
-
Associate - Housekeeping
2 months ago
Tamil Nadu, India Sodexo India On-site Services Full timeAssociate - HK **EXPERIENCE**: - 0 - 2 years **LOCATION**: - No. 77 ,SIPCOT INDUSTRIAL COMPLEX, PHASE II, KUMUDEPALLI, HOSUR, KRISHNAGIRI DIST, TN 635109 THORAPALLY TAMIL NADU 121001 **CONTACT**: - Lavanya.
-
Associate - Housekeeping
2 months ago
Tamil Nadu, India Sodexo India On-site Services Full timeAssociate - HK Unskilled **EXPERIENCE**: - 2 - 3 years **LOCATION**: - No. 77 ,SIPCOT INDUSTRIAL COMPLEX, PHASE II, KUMUDEPALLI, HOSUR, KRISHNAGIRI DIST, TN 635109 THORAPALLY TAMIL NADU 121001 **CONTACT**: - Lavanya.
-
Associate, Regulatory Analysis and Reporting Ii
3 weeks ago
Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full timeAssociate, Regulatory Analysis and Reporting II **_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, Fund Administration Ii
4 days ago
Chennai, Tamil Nadu, India The Bank of New York Mellon Corporation Full timeAssociate,Fund Administration Representative II 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...
-
Plmds Associate Ii
2 months ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Associate, Marketing
7 days ago
Chennai, Tamil Nadu, India BNY Mellon Full time**Overview** 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 our clients that...
-
Associate, Fund Reporting Ii
2 weeks ago
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview 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...
-
Associate, Fund Reporting Ii
6 days ago
Chennai, Tamil Nadu, India BNY Mellon Full time**Overview** **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...
-
Chennai, Tamil Nadu, India BNY Mellon Full timeOverview Associate II - Regulatory Oversight Management 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...