Senior Manager I-Global Regulatory Sciences-CMC
7 months ago
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Position Summary
The GRS-CMC Sr. Manager I is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Sr. Manager I will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC Sr. Manager I will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
Key Responsibilities
Support project matrix teams for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions.
Provide strategic CMC regulatory expertise for development project teams.
Provide strategic input to development and commercial teams to mitigate drug supply issues.
Interpret global regulations and guidance.
Identify, communicate and propose resolution to routine issues.
Participate in product fact finding meetings.
Interface (either directly or indirectly) with the US FDA for CMC submissions and CMC-related issues.
Communicate with project teams; in particular with regards to technical issues that may impact regulatory submissions, strategy, or success.
Provide technical teams insight into regulatory health authority expectations.
Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success.
Ensure the necessary updates are provided to team leaders.
Qualifications & Experience
Minimum BA/BS Degree
3-5+ years pharmaceutical or related experience. 2+ years CMC regulatory or related experience.
Knowledge of global CMC regulatory requirements for pharmaceutical small molecules and/or biologic products during development and post-approval.
Demonstrated ability to develop/maintain strong working relationships with cross functional teams, participate on and/or lead multifunctional teams, and handle/prioritize multiple projects and work independently.
Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
Ability to interpret global regulations and guidance documents.
Strong oral and written skills.
Proficient with electronic systems.
#HYDDD
-
Associate Director, Global Regulatory Sciences-CMC
6 months ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Associate Director, Global Regulatory Sciences
6 months ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Regulatory Sciences Director
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeBristol Myers Squibb is a leader in the pharmaceutical industry, committed to transforming patients' lives through science. We're seeking an experienced Regulatory Sciences Director - Biologics CMC Expert to join our team.Job SummaryThis role requires a highly skilled professional with expertise in biologics CMC regulatory strategy. The successful candidate...
-
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Associate Director, Global Regulatory Sciences
7 months ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob DescriptionTransforming patients' lives through science is a vision that inspires every Bristol Myers Squibb employee. As a GRS-CMC Cell Therapy Associate Director, you will play an integral role in this mission by applying your individual talents and unique perspectives in an inclusive culture promoting diversity in clinical trials.Key...
-
Hyderabad, India Bristol Myers Squibb Full timeDescription The Global Regulatory Sciences – Chemistry, Manufacturing and Controls (GRS-CMC) organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment...
-
Submission Senior Specialist
7 months ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Global Regulatory Sciences Director
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeBristol Myers Squibb is a global biopharma leader that transforms patients' lives through science. We are driven by a passion for innovation, fueled by our commitment to advancing the field of healthcare.About the RoleThe CMC Regulatory Associate Director, Biologics plays a pivotal role in content development, compilation, maintenance, and review of the...
-
Senior Life Science Document Specialist
1 week ago
Hyderabad, Telangana, India Wipro Full timeAbout the RoleWipro is hiring a Senior Life Science Document Specialist in Hyderabad to support our CMC review team.Job Overview:We are seeking an experienced professional to join our team as a CMC Review and Documentation Expert. In this role, you will be responsible for reviewing and documenting CMC information for pharmaceutical and cosmetic products.Key...
-
Senior Regulatory Affairs Associate-Biologics
6 months ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Senior Regulatory Affairs Associate Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends,...
-
Regulatory Submission Expert
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives with Innovative SolutionsBristol Myers Squibb is an organization where unique and interesting work happens every day. We are a global hub focused on helping patients prevail over serious diseases by building sustainable and innovative solutions.About the RoleThe Senior Submission Specialist plays a crucial part in supporting the...
-
Research Fellow
3 months ago
Hyderabad, Telangana, India Ferring Pharmaceuticals, Inc. Full timeJob Description: Position: Research Fellow -CMC (Analytical) Location: Hyderabad Duration: 12 months Reports to: Associate Director - CMC (Analytical) Department: CMC (Analytical) Role Overview: The Analytical Research & Development Intern will assist in the development, validation, and optimization of analytical methods used for the analysis of...
-
Manager I, Regulatory Portfolio Management
6 months ago
Hyderabad, India Bristol Myers Squibb Full timeDescription Position Summary . Position Responsibilities Responsibilities include but not limited to: Global Regulatory Support Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making ...
-
Regulatory Portfolio Management Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeAt Bristol Myers Squibb, we are transforming patients' lives through science. We are seeking a skilled Regulatory Portfolio Management Specialist to join our team.As a Regulatory Portfolio Management Specialist, you will play a vital role in ensuring the success of our regulatory strategies and submissions. Your primary responsibility will be to manage and...
-
Regulatory Submission Professional
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeBristol Myers Squibb is a leading global biopharmaceutical company that transforms patients' lives through science and innovation.We are committed to creating a diverse and inclusive work environment where our employees can grow and thrive.As a Senior Submission Specialist at Bristol Myers Squibb, you will play a critical role in delivering Health Authority...
-
Regulatory Submission Specialist
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob Summary:Bristol Myers Squibb is seeking a highly skilled Regulatory Submission Specialist to join our team. This role plays a critical part in the submission of regulatory documents to health authorities.About the Job:We are looking for an individual with 3+ years of relevant submissions experience, preferably in a science or technology field. The...
-
Regulatory Affairs Associate
6 months ago
Hyderabad, India Parexel Full timeHyderabad, India **Job ID** R0000012328 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Regulatory Affairs Associate** Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned...
-
Global Regulatory Sciences Expert for Biologics
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Global Regulatory Sciences Expert for Biologics to join our team at Bristol Myers Squibb.
-
Regulatory Coordinator
3 months ago
Hyderabad, Telangana, India Novartis Full time**Summary**: - Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment. **About the Role**: **Major...
