Quality Regulatory Manager Job at Randstad (Bengaluru)

Senior Quality Manager – Regulatory Surveillance

We are seeking a self-starting, dynamic Senior Quality Manager to lead regulator...

Location

United States , Boston

Salary:

75.00 - 82.75 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline, operations research, operations management, or related field
Typically 6+ years of relevant experience or equivalent combination of education and experience
Strong facilitation, organization, communication, and influencing skills
In-depth knowledge of global GMP requirements and regulations
Ability to evaluate quality matters and make risk-based decisions
Proven ability to identify and analyze performance indicators
Technical expertise in regulatory compliance, inspections, and quality systems

Job Responsibility

Triage and assess regulatory surveillance items, including new regulations and guidance
Lead cross-functional teams to evaluate the impact of regulations on quality systems and processes
Provide guidance on regulatory expectations, standard industry practices, and implementation options
Support inspection and submission readiness by tracking, reporting, and communicating progress
Present KPIs and metrics to stakeholders to highlight status, risks, and performance

Fulltime

Senior Quality Manager – Regulatory Surveillance

We are seeking a self-starting, dynamic Senior Quality Manager to lead regulator...

Location

United States , Boston

Salary:

75.00 - 82.75 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline, operations research, operations management, or related field
Typically 6+ years of relevant experience or equivalent combination of education and experience
Strong facilitation, organization, communication, and influencing skills
In-depth knowledge of global GMP requirements and regulations
Ability to evaluate quality matters and make risk-based decisions
Proven ability to identify and analyze performance indicators
Technical expertise in regulatory compliance, inspections, and quality systems

Job Responsibility

Triage and assess regulatory surveillance items, including new regulations and guidance
Lead cross-functional teams to evaluate the impact of regulations on quality systems and processes
Provide guidance on regulatory expectations, standard industry practices, and implementation options
Support inspection and submission readiness by tracking, reporting, and communicating progress
Present KPIs and metrics to stakeholders to highlight status, risks, and performance

Regulatory Quality Manager

As the Regulatory Quality Manager at Cambridge Spark, you will be responsible fo...

Location

United Kingdom , Home based, UK (with occasional travel to our London office)

Salary:

Not provided

Cambridge Spark

Expiration Date

Until further notice

Requirements

Substantial experience in regulatory body quality assurance and enhancement, working across both FE/HE quality frameworks
Strong working knowledge of: Further Education requirements, in particular apprenticeships
UK Quality Codes for Education
Regulatory frameworks
Academic governance structures
Experience of programme approval, modification, periodic review and annual monitoring
Experience of supporting validation, accreditation or external review processes
Experience of advising on academic standards, assessment, external examining and curriculum design
Excellent written and verbal communication skills
Strong organisational skills with the ability to manage multiple priorities and deadlines

Job Responsibility

Support designated quality assurance and enhancement activities in line with the institutional quality cycle and monitoring plan
Lead on quality assurance and enhancement activities in the instance of any new provision or regulation types
Develop, implement and maintain academic quality policies, processes and documentation
Monitor and evaluate the effectiveness of quality assurance and enhancement activity
Provide professional support to academic governance structures
Prepare high-quality papers, datasets and reports to support academic decision-making
Service meetings as required
Support preparation for regulatory registration and post-registration engagement
Assist in the preparation for, and response to, external audits, validations, re-validations and reviews
Act as a source of expert advice on regulatory expectations and good practice

What we offer

Pension with 4% matched contributions, opportunity to opt into salary sacrifice scheme
25 days holiday + Flexi bank holidays + 1 day off on your birthday
A day for volunteering
Enhanced Maternity and Paternity Leave
Health & Wellbeing allowance of up to £30 per month
Annual Summer and Xmas events
Company socials
CPD Allowance alongside quarterly reflections to ring fence time for development and growth
Private medical insurance and cash plan
Holiday buy back scheme (up to 10 days p/a)

Fulltime

PMO Sr. Manager, Quality, Regulatory & Safety

The Project Manager, Regulatory, Safety & Quality will act as a strategic partne...

Location

Italy , Milano; Bologna; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

8+ years of experience in biopharma, life sciences, consulting, or strategy roles
Solid exposure to Regulatory Affairs, Pharmacovigilance/Safety, Quality, or closely related development functions
Experience working in highly regulated environments is required
Advanced degree preferred (PhD, MSc, MD, PharmD, MBA, or equivalent), ideally with a scientific or regulatory background
Strong ability to lead through influence in complex, matrixed organizations
Excellent organizational, communication, and analytical skills
High level of discretion, integrity, and ability to manage sensitive and confidential information
Proven experience partnering with senior leaders and coordinating cross-functional initiatives
Solid understanding of regulatory, safety, and quality principles within drug development

Job Responsibility

Translate priorities of the Regulatory, Safety & Quality leadership into actionable plans with clear ownership, timelines, and deliverables
Coordinate the definition and monitoring of annual goals, KPIs, and functional business reviews across Regulatory, Safety, and Quality
Track progress of key initiatives (e.g. submissions, inspections readiness, safety governance, quality systems) and ensure alignment across internal and external stakeholders
Prepare, consolidate, and manage content for leadership team meetings, governance forums, and relevant committees (e.g. Safety Committees, Quality Councils)
Act as a thought partner to the Head of Regulatory, Safety & Quality in short- and long-term planning
Synthesize complex regulatory, safety, and quality information into clear summaries, dashboards, and recommendations to support decision-making
Serve as a central liaison between Regulatory, Safety, Quality, Clinical Development, Operations, Biometrics, and other relevant functions
Ensure timely follow-up and accountability on decisions and action items
Facilitate effective information flow with external partners, vendors, and consultants where applicable
Support and evolve governance frameworks related to Regulatory, Safety, and Quality (e.g. risk management, inspection readiness, compliance oversight)

Regulatory Quality Assurance Manager

We are looking for a highly skilled Regulatory Quality Assurance Manager to join...

Location

United Kingdom , Guildford

Salary:

Not provided

Alliance Medical Ltd

Expiration Date

Until further notice

Requirements

Degree or equivalent experience in Quality, Regulatory, or a pharmaceutical discipline
Minimum of 5 years' regulatory experience, ideally within radiopharmacy, sterile manufacturing or aseptic processing
Proven experience with GMP, MHRA expectations and broader GxP requirements
Experience supporting commercial and IMP product development, including clinical trial supply
Strong understanding of regulatory inspections and authority interactions
Experience working across multi-site operations with consistent quality standards
Excellent communication, organisational and interpersonal skills
Strong attention to detail, proactive approach and ability to work independently
Proficiency in Microsoft Word, Excel, PowerPoint and general Windows applications

Job Responsibility

Overseeing GMP, GDP and MHRA compliance across multiple radiopharmacy sites
Acting as QA regulatory lead for Commercial and IMP activities, including IMPD reviews and clinical trial processes
Supporting MHRA and regulatory authority interactions, including inspections, audits and follow-up commitments
Maintaining site licences, variations and regulatory submissions in line with operational needs
Harmonising quality systems across sites, including deviations, CAPAs, change control and documentation
Providing QA input into product development, validation and technology transfer activities
Reviewing and approving key documentation such as SOPs, validation protocols and batch records
Contributing to the implementation of a new electronic QMS
Driving inspection readiness and a strong quality culture across the UK network
Deputising for the Head of Quality when required

Fulltime

Manager, Regulatory Affairs & Quality Assurance

NYES is seeking an accountable and specialized Manager of Regulatory Affairs & Q...

Location

United States , Brooklyn

Salary:

Not provided

New York Embroidery Studio

Expiration Date

Until further notice

Requirements

5–10 years of specific experience in Regulatory Affairs for PPE manufacturing, with a proven track record of successful FDA clearances
Comprehensive knowledge of FDA Class I and II medical device classifications, ASTM testing methods, and NIOSH approval standards
Strong background in implementing and maintaining Quality Management Systems (QMS) compliant with federal standards (21 CFR 820) and international standards (ISO 13485)
RAPS (Regulatory Affairs Certification) and Six Sigma Black Belt (preferred)
A professional who seeks full accountability and can coordinate complex, cross-functional teams to achieve compliance goals

Job Responsibility

Serve as the primary lead for the development, implementation, and continuous improvement of the ISO 13485 Quality Management System, ensuring all manufacturing and quality processes maintain international certification
Lead the preparation and submission of FDA 510(k) premarket notifications for medical-grade PPE (e.g., surgical masks, isolation gowns, etc.) to ensure products are “FDA-cleared.”
Oversee adherence to 21 CFR Part 820 (Quality System Regulation) for all PPE manufacturing processes and controls
Manage the certification and approval process with NIOSH for respiratory protective devices, such as N95 respirators
Ensure materials meet rigorous ASTM International standards for barrier performance, including fluid resistance (ASTM F903) and viral penetration (ASTM F1671)
Act as the primary point of contact for government agencies, ensuring manufacturing and marketing practices align with OSHA requirements
Direct the development of labeling and packaging to ensure accurate regulatory claims and prevent the marketing of unverified equipment
Partner with product development and commercial teams to navigate registration processes and ensure timely product launches

Quality and Regulatory Manager

This role is supporting our AmerisourceBergen business, which offers supply chai...

Location

United States , Cincinnati

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Broad training in fields such as Life Science or related field, business administration, or similar vocations generally obtained through completion of a four-year bachelor’s degree program or equivalent combination of experience and education
normally requires a minimum of four (4) years directly related and progressively responsible experience
Process-oriented, Continuous Improvement experience such as Lean Six Sigma
Good understanding of local, state, and federal laws and regulations. and knowledge of the agencies that regulate the BU location
Detailed understanding of all drug distribution practices and procedures
Ability to communicate effectively both orally and in writing
Effective presentation and training skills
Strong interpersonal skills
Strong leadership skills
Effective negotiation skills

Job Responsibility

Assuring the business unit (BU) location maintains a robust, effective Quality Management System and security & regulatory compliance effort that aligns with Cencora's policy and procedures, as well as state and federal regulations
Ensure compliance with the principles of Good Distribution Practices (GDP)
Facilitate knowledge transfer throughout the operation to help build a Quality and Regulatory Compliance Culture
Responsible for the maintenance, execution, and monitoring of the BU Location’s Quality Management System (QMS), Good Distribution Practices (GDP), and compliance with all local state (BOP, DOH, etc.), and federal regulations (DEA, EPA, FDA, OSHA, etc.) as well as all corporate policies and procedures
Monitors, verifies, and maintains all BU location local, state, and federal licensure and registrations as required
Acts as primary liaison between BU location and all local, state, and federal regulatory agencies
Manages and/or assists with all inspections, investigations, and information requests
Conducts required Quality, Health & Safety, Security and Regulatory Assessments
Promotes a culture of Quality across the BU location
Responsible for collaborating with BU location on implementation of annual Quality Objectives and Key Business Drivers established for DC operations

What we offer

Medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families which may include backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions
paid parental leave

Fulltime

Quality & Regulatory Affairs Manager

We’re looking for a Quality & Regulatory Affairs Manager who’s passionate about ...

Location

United States; Canada , Boston; Chicago; Ottawa; Toronto

Salary:

Not provided

Fullscript

Expiration Date

Until further notice

Requirements

5+ years of progressive experience in regulatory affairs or quality compliance within dietary supplements and/or NHPs
Working knowledge of FDA dietary supplement regulations (21 CFR 111, DSHEA, NSF 455-2) and Health Canada NHP frameworks
Experience supporting or preparing for FDA, NSF, or Health Canada inspections
Proven ability to manage labeling, claims, supplier documentation, and GMP records with precision
Strong communicator with the confidence to collaborate across teams and influence without authority
Bachelor’s degree in life sciences, chemistry, or a related field

Job Responsibility

Maintain ongoing compliance with FDA 21 CFR 111, DSHEA, and NSF 455-2 for finished dietary supplements
Manage Health Canada NHP site and product licensing, importation compliance, and regulatory documentation
Review and approve labels, claims, and substantiation for dietary supplements and NHPs
Support audit readiness for FDA, NSF, and Health Canada inspections, including CAPA documentation and process follow-up
Oversee facility registrations, supplier qualifications, and product listings across U.S. and Canadian markets
Partner with Quality, Legal, and Distribution to resolve compliance issues and strengthen product lifecycle controls
Monitor regulatory updates and proactively align internal processes to new requirements
Contribute to SOP, QMS, and continuous improvement initiatives that reinforce Fullscript’s compliance excellence

What we offer

Market competitive compensation package including equity
401K matching (within US)//RRSP matching (within CAD)
Flexible PTO policy
Flexible benefits package and additional perks
Employee discount on Fullscript catalog of products for family & friends
Ability to *Work Wherever You Work Well*

Fulltime

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Quality Regulatory Manager

Job Description

Requirements

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