Senior Regulatory Affairs Specialist Job at Blackmores Group (Warriewood, NSW)

Global Supplier Quality Senior Specialist

The Senior Specialist, Global Supplier Quality is responsible for driving suppli...

Location

Italy , Pomezia; Milano; Bologna; Alanno

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 7 years’ experience in supplier quality management within pharmaceuticals, medical devices, or food supplements
Strong working knowledge of GMP, ISO 13485, HACCP, and global regulatory expectations
Demonstrated success in supplier audits, risk-based quality management, and compliance oversight
Lead Auditor certification highly desirable
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Engineering, or a related technical field
Proven experience using digital tools and systems for supplier qualification and performance management
Exceptional communication, stakeholder management, and problem-solving skills
Ability to operate effectively in a fast-paced, matrixed, and multicultural environment
Fluency in English required
Strong proficiency with Microsoft Office Suite and other business platforms

Job Responsibility

Lead global supplier qualification, approval, and requalification processes in alignment with corporate and regulatory standards
Develop and maintain comprehensive supplier risk assessments and qualification documentation
Oversee the full supplier lifecycle — from onboarding and performance monitoring to periodic reviews and requalification
Plan, conduct, and report supplier audits (both on-site and remote) to verify compliance with internal and external standards
Ensure adherence to GMP, ISO 13485, HACCP, and other applicable global quality and regulatory frameworks
Partner with suppliers to address audit findings, implement corrective and preventive actions, and monitor their effectiveness
Support site quality operations in reviewing and approving supplier-provided documentation, including change controls, technical files, and periodic reviews
Maintain and update Supplier Quality Agreements, ensuring alignment with internal policies and regulatory requirements
Contribute to the preparation and successful execution of regulatory inspections and customer audits related to supplier management
Proactively identify and mitigate supplier-related risks impacting product quality or supply continuity

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Regulatory Affairs Senior Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

United States

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 3-5 years’ experience in Regulatory Affairs
or equivalent combination of education and experience
Experience working in the pharmaceutical industry
Ability to prioritize and drive multiple projects
Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines
Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA
Ability to maintain confidentiality and responsive to client needs
Ability to adapt under regularly changing conditions

Job Responsibility

Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients
Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications
Drafts and manages regulatory submissions
Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files
Coordinates regulatory fee payments on behalf of client
Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence)
Liaises with regulatory authorities on behalf of clients (e.g., US Agent)
Builds, develops and maintains working relationships with clients
Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner
Performs basic document management tasks including file transfer, storage, tracking, and archival

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
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions

Fulltime

Senior Regulatory Affairs Specialist – Regional

This role offers an exciting opportunity to provide regional regulatory support ...

Location

Malaysia , Petaling Jaya

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Pharmacy, Science, or equivalent
Minimum 6 years of regulatory experience in the medical devices industry
Strong expertise in new registrations, license extensions, variations, and renewals, with mandatory experience in Class II devices and above
In‑depth knowledge of regulatory laws, acts, and evolving requirements
Solid understanding of GDPMD standards
Skilled in project management, multitasking, and prioritization
Excellent interpersonal, communication, and negotiation skills
Proficiency in technical systems (word processing, spreadsheets, databases, online research)
Ability to identify compliance risks and escalate effectively

Job Responsibility

Develop and execute regulatory project plans that keep products moving efficiently through approval pathways
Identify and escalate regulatory risks early, ensuring proactive solutions
Stay ahead of evolving regulations and translate requirements into clear, actionable steps
Maintain accurate and compliant regulatory files and documentation
Actively contribute to project teams, offering practical regulatory guidance
Respond to inquiries from regulatory authorities within strict timelines
Compile, prepare, and submit new registrations, variations, renewals, and change notifications to secure timely approvals
Review and approve labeling and promotional materials to ensure compliance with local regulations
Represent Regulatory Affairs in project teams, supporting business objectives and compliance standards
Manage post‑market surveillance (PMS), field actions, and complaints in Singapore and Malaysia

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

New

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cunesoft

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen; Brussels

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

Senior Regulatory Affairs Specialist

New RA position dedicated to the Reusable Pen Platform and its 2 strategic custo...

Location

United States , Franklin Lakes

Salary:

59.00 - 63.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
Medical device and international registration experience is a must
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
Strong project management and communication (verbal, written) and skills
Able to independently handle multiple tasks/projects with minimum supervision
Self-starter with the ability to take over responsibilities
Team player, Attention to details, Highly result-oriented
Flexible and reliable personality
ability to manage stressful situations
High personal integrity and ethical standards

Job Responsibility

Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
Identify ways to improve the efficiency of current work process and best practices as necessary.

What we offer

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.

Fulltime

Regulatory Affairs Specialist

An excellent opportunity to join a leading global food business based in central...

Location

United Kingdom , London

Salary:

45000.00 - 50000.00 GBP / Year

The People Co.

Expiration Date

Until further notice

Requirements

5+ years of technical or regulatory experience in food, feed or ingredients
Highly analytical, and organised with keen attention to
Must be able to identify problems and provide systematic
Be able to multi-task and have excellent communication skills
Real team player – Must be able to work with senior and junior employees in a professional and inclusive manner
A high level of business English is essential
The successful candidate will be self-motivated
Strong administration skills on Microsoft Office Packaging on Windows

Job Responsibility

Ensure regulatory compliance with food and feed safety, quality and defence as it relates to UK, EU and GFSI (BRC) requirements, Organic, Halal, FAMI QS and Kosher
Monitor changes in legislation and regulatory requirements, proactively assessing the impact on business and updating the senior management team's compliance protocols as necessary
Support the development and implementation of regulatory strategies for existing ingredients and new ingredients/products in the UK and EU regions ensuring compliance to but not limited to Allergens, REACH, Novel food, Packaging Food Contact Materials, Food Law and labelling, Feed laws and labelling, Residues and Contaminants, Natural and Botanical ingredients etc
Provide regulatory review of product compliance when an in-depth analysis/review is needed for the quality department. Example of review provided: Novel food status, specific application status, claims, labelling
Coordinate with authorities for all work required, such as authorisation and licenses
Support the design and maintenance of Prinova Specification, ensure all information is correct and meets relevant EU regulation requirements
Provide training for the quality and technical teams in Europe
Actively support QA department tasks according to workload and priorities, as required
Provide support to the commercial and marketing team to verify regulatory compliance
Assisting, as required, in the management of crises and incidents as part of the management team

Senior Regulatory Affairs Specialist

Blackmores Group

Location:
Australia , Warriewood, NSW

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 22, 2026

Expiration:
March 30, 2026

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Blackmores Group

Location:Australia , Warriewood, NSW

Category:Pharmacy

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:March 22, 2026

Expiration:March 30, 2026

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Location:
Australia , Warriewood, NSW

Category:
Pharmacy

Contract Type:
Not provided

Job Posted:
March 22, 2026

Expiration:
March 30, 2026