Associate Ii

1 week ago

Chennai Tamil Nadu, India Pfizer Full time

Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee.

Has fundamental knowledge of the principles and concepts of process been followed, the activities which includes but not limited to:

- Authors and/or compiles CMC contributions for renewals, i.e. Module 1, M2.3.S/P, M3.2.S/P/R/A. Collaborates with GRS-CMC/RRHS as appropriate and within agreed timelines.
- Liaise with Pfizer Global Supply and other support functions as needed.
- Applies pertinent regulatory guidelines for authoring renewals.
- Executes renewals regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC/RRHS. Supports Query and/or commitment management in collaboration with GRS-CMC.
- Reviews technical/supportive information for submission to support renewals.
- Updates impacted dossier components as needed. Escalates delays in timelines and contributes to the Identification and mitigation of risks with the support of TL/designee; flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates M1/M3.2.R Ancillary documents as needed.
- Coordinates internal document review and sign off.
- Utilizes Pfizer’s systems, i.e. PEARL, GDMS, PDM, SPA, etc., as appropriate.
- Preferred Education:
Minimum - Undergraduate/Postgraduate in Pharmacy or Science
- Preferred Experience:
Minimum 2 - 4 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization
- Preferred Attributes:
Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.
- Technical Skills:

- Knowledge on Regulatory requirements of post approval changes for global market.
- Knowledge in retrieving information from company’s and regulatory agency databases.
- Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

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, 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 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 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 “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 time

    Overview 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 time

    Overview 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 time

    Overview 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 time

    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, Cash Processing/funds Transfer Ii

    7 days ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview 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 time

    Associate - 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 time

    Associate - 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 time

    Associate, 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 time

    Associate,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 time

    Why 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, Fund Reporting Ii

    2 weeks 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...

  • 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

    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...

  • Associate, Regulatory Analysis and Reporting Ii

    5 days ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview 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...