Submission Specialist
1 week ago
Working with Us
Bristol Myers Squibb is a company that offers challenging and meaningful work opportunities. Our team is dedicated to helping patients prevail over serious diseases by building sustainable and innovative solutions.
The Submission Manager will manage and coordinate the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.
Key Responsibilities:
- Provides advice regarding regulatory and submission requirements, dossier content, and format using in-depth knowledge of eCTD submission production.
- Supports the execution of the Global Submission Plan through collaborating with team members and vendors.
- Tracks progress of all components for submission to Health Authorities.
- Facilitates submission team meetings and interacts with responsible parties to ensure timely delivery of components.
- Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships, and divestitures.
- Attends submission team meetings and represents the Submission Manager.
Requirements:
- BA/BS degree, science/technology field preferred.
- 5+ years relevant submissions experience.
About the Role:
This is a unique opportunity to work with a global leader in the pharmaceutical industry. As a Submission Manager, you will be responsible for managing and coordinating submission documents and dossiers to health authorities.
What We Offer:
Bristol Myers Squibb offers a dynamic and challenging work environment with opportunities for growth and development. We provide a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to Apply:
Please submit your application, including your resume and a cover letter, to [insert contact information].
-
Submission Specialist
2 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob Summary:We are seeking a skilled Submission Specialist to join our team at Bristol Myers Squibb. The ideal candidate will have a strong background in regulatory submissions and experience working with global regulatory practices and submission guidelines.Key Responsibilities:Coordinates submission team meetings and facilitates submission publishing...
-
Submission Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Submission Senior Specialist to join our team at Bristol Myers Squibb. The ideal candidate will have a strong background in regulatory submissions and excellent communication skills.Key ResponsibilitiesPrepare and submit high-quality regulatory documents to Health Authorities.Collaborate with cross-functional teams...
-
Submission Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJoin Our Team at Bristol Myers SquibbBristol Myers Squibb is a leading pharmaceutical company that is committed to transforming the lives of patients through innovative solutions. We are seeking a highly skilled Submission Senior Specialist to join our team in Hyderabad, India.About the RoleThe Senior Submission Specialist will play a critical role in...
-
Submission Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Submission Specialist to join our team at Bristol Myers Squibb. As a key member of our regulatory affairs team, you will be responsible for coordinating and submitting regulatory documents to Health Authorities.Key ResponsibilitiesCoordinate and track all components for submission to Health AuthoritiesInteract with...
-
Submission Senior Specialist
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Submission Senior Specialist to join our team at Bristol Myers Squibb. As a key member of our regulatory affairs team, you will be responsible for coordinating and managing the submission process for our products.Key ResponsibilitiesCoordinate and manage the submission process for our products, ensuring timely and...
-
Regulatory Submissions Specialist
1 week ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob Summary:The Regulatory Submissions Specialist will be responsible for coordinating and managing the submission process for Investigational, Marketed Applications submissions. This includes preparing Cover Letters, FDA Forms, and submission content plans, as well as facilitating submission team meetings and coordinating non-eCTD submissions.Key...
-
Submission Operations Specialist
1 week ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeUnlock Your PotentialBristol Myers Squibb is a leader in the pharmaceutical industry, and we're looking for a skilled Submission Senior Specialist to join our team. As a key member of our Regulatory Information and Submission Management (RISM) organization, you'll play a critical role in delivering health authority submissions and product data that support...
-
Submission Specialist
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Submission Specialist to join our Regulatory Affairs team at Bristol Myers Squibb. The ideal candidate will have a strong background in regulatory submissions and excellent communication skills.Key ResponsibilitiesCoordinate and prepare submission documents for Investigational, Marketed Applications submissions...
-
Senior Submission Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Lives through Regulatory ExcellenceBristol Myers Squibb is a global leader in the pharmaceutical industry, and we're seeking a highly skilled Senior Submission Specialist to join our team. As a key member of our Regulatory Information and Submission Management (RISM) organization, you will play a critical role in delivering high-quality...
-
Senior Regulatory Submissions Specialist
2 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob DescriptionBristol Myers Squibb is seeking a skilled Senior Submission Specialist to join our team at RISM. This role is responsible for coordinating and submitting high-quality documents to Health Authorities, working closely with internal stakeholders to ensure timely and compliant submissions.Key ResponsibilitiesPrepare and submit Investigational,...
-
Senior Submission Specialist
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransformative Work at Bristol Myers SquibbAt Bristol Myers Squibb, we're pushing the boundaries of what's possible in the world of healthcare. Our team is dedicated to delivering innovative solutions that transform the lives of patients and the careers of those who work with us.Role SummaryThe Senior Submission Specialist plays a critical role in supporting...
-
Regulatory Publishing Specialist
4 weeks ago
Hyderabad, Telangana, India 2083 DXC Technology India Private Limited Full timeJob Description:As a Regulatory Publishing Specialist at 2083 DXC Technology India Private Limited, you will play a crucial role in ensuring the successful publication of regulatory submissions. Your primary responsibility will be to assemble, distribute, and publish submissions within the specified training period.Key Responsibilities:Meet and complete...
-
Regulatory Publishing Specialist
1 week ago
Hyderabad, Telangana, India 2083 DXC Technology India Private Limited Full timeJob Summary:We are seeking a highly skilled Regulatory Publishing Specialist to join our team at 2083 DXC Technology India Private Limited. The ideal candidate will have a strong background in life sciences and pharmaceutical industry, with experience in regulatory publishing and submission publishing.Key Responsibilities:Meet and complete training...
-
Regulatory Publishing Specialist
4 weeks ago
Hyderabad, Telangana, India 2083 DXC Technology India Private Limited Full timeJob Title: Analyst III Regulatory PublishingJob Summary:We are seeking a highly skilled Regulatory Publishing Specialist to join our team at 2083 DXC Technology India Private Limited. The successful candidate will be responsible for performing submission publishing, assembly, and distribution activities within the specified training period.Key...
-
Regulatory Portfolio Management Specialist
2 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob Summary: We are seeking a highly skilled Regulatory Portfolio Management Specialist to join our team at Bristol Myers Squibb. In this role, you will be responsible for providing regulatory support and expertise to ensure compliance with health authority regulations and standards.Key Responsibilities:Liaise with cross-functional teams to generate periodic...
-
US Labeling Operations Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced US Labeling Operations Specialist to join our team.Key ResponsibilitiesEnsure accuracy, consistency, and alignment of Bristol-Myers Squibb labeling...
-
Regulatory Portfolio Management Specialist
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob Summary We are seeking a highly skilled Regulatory Portfolio Management Specialist to join our team at Bristol Myers Squibb. As a key member of our regulatory team, you will be responsible for providing global regulatory support and strategy to ensure compliance with regulatory requirements. Key ResponsibilitiesCo-lead GRST meetings to ensure...
-
Business Development Specialist
3 weeks ago
Hyderabad, Telangana, India POWER BRIDGE SYSTEMS PRIVATE LIMITED Full timeWe are seeking a skilled Business Development Specialist to support our team at POWER BRIDGE SYSTEMS PRIVATE LIMITED. The ideal candidate will be responsible for coordinating relationships with vendors, creating proposals in Zoho Books, and ensuring high customer satisfaction through quick proposal submission and regular follow-ups. The candidate should have...
-
Technical Document Specialist
2 weeks ago
Hyderabad, Telangana, India GVR TECHNOLABS PRIVATE LIMITED Full timeAbout GVR Technolabs Pvt LtdWe are an Information Technology services company with expertise in design, deployment, and management of hardware and software applications and technology infrastructures.Job Description:As a Technical Document Specialist, you will be responsible for collecting project information, understanding the data provided, and preparing...
-
Regulatory Portfolio Management Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Regulatory Portfolio Management Specialist to join our team at Bristol Myers Squibb. As a key member of our regulatory team, you will be responsible for providing global regulatory support and ensuring compliance with regulatory requirements.Key ResponsibilitiesCo-lead GRST meetings to ensure high-quality...