Regulatory Affairs (Pharma) Job at Randstad (Shanghai)

Regulatory Affairs Pharma

The Regulatory Affairs Specialist is responsible for providing procedural, admin...

Location

Belgium , Brussels

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

University degree (or equivalent, e.g., A1 in Belgium), preferably in a scientific discipline related to medicine (e.g., Pharmacy, Life Sciences, Medicine, Biology, Chemistry)
4–6 years of experience in the pharmaceutical industry, with solid knowledge of the drug development and/or approval process
Proven experience in EU regulatory submissions (centralized and/or decentralized/MRP) and lifecycle management is a strong asset
Good command of English (written and spoken)

Job Responsibility

Provide administrative regulatory support during the filing and review of new submissions and variations to ensure compliance with EU requirements
Plan and coordinate new submissions, variations, CHMP referrals, and FUM to ensure timely submission
Draft Module 1 components and coordinate the collection and organization of all Module 1 documentation
Collaborate closely with Regulatory Operations to define submission timelines and Module 1 content
Work in close partnership with Country RA Registration Managers to secure timely submissions in all relevant markets
For centralized procedures, supervise and coordinate the translation process to ensure on‑time submission to EMA
Provide additional administrative support related to Marketing Authorization Applications to senior Regulatory Affairs staff (Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist, Senior Scientist) as needed
Ensure accurate and timely updates to regulatory databases and tracking tools
Stay current with EU procedural requirements, guidelines, and legislation, and apply them in daily activities
Participate as Subject Matter Expert (SME) in relevant workstreams and projects as assigned by Regulatory Affairs Europe senior leadership

What we offer

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Fulltime

Global Regulatory Affairs Manager, Pharma Strategy

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Sciences or similar
Solid experience in Regulatory Affairs within pharma/healthcare (FMCG experience is a strong plus)
Proven track record in regulatory strategy and variation management
Experience with DCP, MRP, and national procedures
Strong project management skills in fast-paced, cross-functional environments
Ability to navigate complexity and balance strategic thinking with hands-on execution
Experience working with regulatory authorities and external stakeholders
Fluent in English

Job Responsibility

Lead global regulatory strategy and act as RA project lead for key initiatives (MAAs, M&A, NPD, EPD)
Drive regulatory planning, execution, and submissions across multiple markets
Prepare and review core regulatory documentation (Modules 2, 4, 5) and authority responses
Manage submissions including variations, PSURs, and renewals
Collaborate cross-functionally with Scientific Affairs, Operations, and Commercial teams to ensure alignment and execution
Act as the regulatory voice in strategic discussions, influencing business decisions
Build and maintain strong relationships with regulatory authorities
Develop and continuously improve SOPs and regulatory processes

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule and life work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a young, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Regulatory Affairs & Quality Assurance Associate

NYES is looking for a motivated, detail-oriented Regulatory Affairs & Quality As...

Location

United States , Brooklyn

Salary:

Not provided

New York Embroidery Studio

Expiration Date

Until further notice

Requirements

Recent Regulatory Affairs and Quality Assurance (RAQA) Graduate Program
1–2 years of experience in a regulated industry (MedTech, Biotech, or Pharma)
Internship experience in RA/QA is highly valued
Understanding of FDA Class I and II medical device classifications
Familiarity with ISO 13485 and 21 CFR 820 frameworks
High level of technical writing proficiency
attention to detail
a "student of the craft" mentality
A clear desire to grow into a leadership role within NYES

Job Responsibility

Assist the Manager in the daily maintenance of the ISO 13485 Quality Management System, including document control and CAPA tracking
Support the preparation of FDA 510(k) premarket notifications and NIOSH approval packets for N95 respirators and surgical masks
Perform routine checks to ensure manufacturing processes align with 21 CFR Part 820 (Quality System Regulation)
Draft and update Standard Operating Procedures (SOPs), labeling, and IFUs (Instructions for Use) to ensure accurate regulatory claims
Work with third-party labs to track ASTM barrier performance testing (fluid resistance, viral penetration) and organize results for regulatory dossiers
Participate in internal audits and assist in preparing the facility for external inspections from the FDA or Notified Bodies

What we offer

Direct Mentorship: Learn from a veteran Lead with 5–10 years of specialized PPE experience
Clear Career Path: This isn’t just a job
it’s a prepared seat
Impact: Your work ensures that frontline healthcare workers receive PPE that is safe, cleared, and effective

Fulltime

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Regulatory Affairs Associate

Our client, a personal care product manufacturing company, is looking for a Regu...

Location

United States , Clark

Salary:

36.76 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor's degree in a science or a related field
Experience in pharma or consumer care industry
Regulatory background in personal care/cosmetics industry

Job Responsibility

Regulatory Compliance: Review raw materials and product formulas against regulatory requirements
Track global regulatory changes and managing product notifications and registrations to ensure up-to-date compliance
Work on large volumes of data

What we offer

medical
dental
401(k)
direct deposit
commuter benefits

Regulatory Affairs Labelling Manager

Proclinical is seeking a Regulatory Labelling Manager to support the development...

Location

United Kingdom , Hertfordshire

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent in life sciences or a related field
Strong knowledge of regulatory affairs, particularly in strategic labeling
Proven ability to lead cross-functional matrix teams with strong influencing skills
Excellent interpersonal and verbal communication skills

Job Responsibility

Develop and maintain Core Data Sheets (CDS) for medicinal products, ensuring alignment with regulatory requirements
Provide guidance and expertise to product teams on CDS and supporting documentation
Author and manage CDS processes in collaboration with regulatory product leads and product teams
Create and maintain EU and US product information packages, including responses to health authority questions
Offer strategic recommendations on labeling requirements for regional markets in collaboration with relevant functions
Support the implementation of CDS into local product labels and manage any deviations
Provide guidance on regulatory labeling issues, including legislation, guidelines, and procedures
Lead or contribute to the establishment and improvement of labeling processes and standards

Select Country

Regulatory Affairs (Pharma)

Job Description

Requirements

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