Associate Director, Global Regulatory Sciences-CMC
6 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.
The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products 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 Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.
Position Summary / Objective
The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products 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 Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.
Position Responsibilities
Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research Independently provide strategic guidance/input related to current regulatory requirements and expectation for small molecule marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products. Independently manage and prioritize multiple complex projects Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics. Identify, communicate and propose resolutions to routine/complex issues Interpret global regulations and guidance. Identify regulatory opportunity and risks. Anticipate and communicate possible regulatory paradigm shifts Participate in product fact finding meetings Review and provide regulatory assessments on change controls Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents Mange relationships with diverse teams Utilize electronic systems for dossier creation and tracking.Degree Requirements
Minimum BA/BS Degree
Experience Requirements
7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy. Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for small molecule products. Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods. Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently. Ability to identify, communicate and resolve complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness. Ability to interpret global regulations and guidance.Key Competency Requirements
Strong oral and written skills.
Proficient with electronic systems
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
-
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...
-
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, 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, 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...
-
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, 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...
-
Senior Manager I-Global Regulatory Sciences-CMC
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...
-
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...
-
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...
-
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...
-
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,...
-
Senior Research Associate/ Asst. Scientist
5 months ago
Hyderabad, India Ferring Pharmaceuticals Full timeJob Description:Role: Senior Research Associate / Asst. ScientistReporting to: Associate Director – CMC (Analytical)Location: HyderabadExperience: 7 to 10 years of industrial experience in analytical development of formulations. Working experience with complex injectables, hydrogels, large molecules, peptides etc. preferredQualification: M. Pharma/M.Sc. in...
-
Asst. Scientist
5 months ago
Hyderabad, India Ferring Pharmaceuticals Full timeJob Description:Role: Asst. Scientist / Scientist - CMC (Analytical)Reports to: Associate Director - CMC (Analytical)Location: Hyderabad, IndiaQualification: Ph.D. (preferred), M. Pharma/M.Sc. in Pharma Chemistry from reputed University.Experience: M. Pharma/M.Sc. in Pharma Chemistry with around 9 -14 years of experience or PhD in Pharmaceutical...
-
Principal Cmc Statistician
7 days ago
Hyderabad, Telangana, India Amgen Full timeJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four...
-
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...
-
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...
-
Associate, Regulatory Affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title:Associate, Regulatory AffairsReports To:Director, Regulatory AffairsLocation:Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...
-
Associate, Regulatory Affairs
1 month ago
hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
-
Associate, regulatory affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
