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Manager I, Regulatory Portfolio Management

5 months ago

hyderabad, India Bristol Myers Squibb Full time

Description

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

Execution of Regulatory Strategy

Liaise cross-functionally to generate periodic internal milestone report

Communicate status and timeline changes

Tracking key regulatory milestones as defined by the GRT, health authority meetings, post-approval commitments, annual reports, etc.

Regulatory Intelligence

Monitors key Health Authority Websites for pertinent information

Compiles Regulatory precedents as requested

Creating and supporting database for Global Submission Country requirements (CMC, IVDR,…)for new and Post Approval submissions

Global Regulatory Submissions Support

Support CMC Leads to gather auxiliary (country specific) documentation for clinical and commercial Rest of World submissions (non-Module 1. Example: support to collate documents / getting the Annexes for GMP dossiers (e.g. for Turkey, Korea, Thailand)

Support submission team meetings ROW

Support of Divestitures / Product Deletions / Product Termination / Asset Integration

Product Divestiture:

Works with the Divestiture Reg Lead to document any gaps to be disclosed to the buyer

Works with Divestiture Reg Lead on implementation of MAT transfers, provides status updates

HA queries / Shortage Notifications

Schedule RRT meetings and communicate timelines

Set up response templates to ensure submission readiness

Submission of responses for publishing

Follow-up with SME in response sections

Analytics / Compliance Activities

Support preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stones

Review Verity and Infinity reports for Compliance related trends, eg HA commitments, Development commitments, openCAPAs, CAPAs coming due

Degree Requirements

Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field

Experience Requirements

Qualifications/Requirements: 

≥ 3 years in pharmaceutical industry and regulatory experience

Key Competency Requirements

Solid understanding of at least one major Health Authority (FDA, EMA, MHRA …..) regulations and Regulatory standards

Act as a role model & set a good example

Identify, resolve and manage completion of issues. Articulate the implication of issue to and across project team on risk/benefit strategic component.

Excellent communication and organizational skills and a meticulous eye for details

Facilitate negotiation with HAs & key partners on routine matters w/ supervisory consultation.

Ability to make decisions in their sphere of influence

Independently work on multiple projects & assignments.

Ability to lead cross-functional teams under supervision

Must possess an excellent command of language (English)

Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed

Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities

Travel Required (nature and frequency). Enter “N/A” if not applicable.

N/A

Describe exposure to any hazards/disagreeable conditions in the work environment. Enter “N/A” if not applicable.

NA

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.