Junior Regulatory Affairs Associate Job at Parexel (Petaling Jaya)

Global Regulatory Affairs Lead, Wellbeing Collective

Lead global regulatory strategy for a fast-growing health supplement business (W...

Location

United States , Hoboken

Salary:

227700.00 - 569250.00 USD / Year

Unilever

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Science (e.g., Pharmacy/Pharm D, Biology, Chemistry) or a higher degree (Ph.D.)
A specialized degree in Regulatory Affairs is highly desirable
Minimum 10+ years of progressive experience in Regulatory Affairs within the Consumer Healthcare or Nutraceutical industry
Demonstrated success in developing and executing regulatory strategies for health products across multiple global regions and different product categories
Proven experience in a global lead regulatory role with a comprehensive understanding of regional regulatory requirements and dynamics across multiple regions (U.S., EU, and/or other international markets)
Strong knowledge of global regulatory requirements and submission formats
Proven experience managing complex regulatory deliverables across product lifecycle stages
Significant experience in interactions with FDA, EMA, and other global regulatory agencies
Deep understanding of the product development process for ingestible health products
Strong sense of urgency and ability to react decisively to regulatory alerts, product challenges, and sustainability trends

Job Responsibility

Build a unified, scalable regulatory capability across a diverse portfolio of acquired businesses and international organization
Develop and Champion Strategy: Define and execute the comprehensive, long-term regulatory strategy for Wellbeing portfolio globally, ensuring alignment with commercial goals
Drive Innovation Pipeline: Serve as the regulatory lead in the global innovation process, providing scientific and regulatory input for new product development, and market entry, including claims support
Opportunity Identification: Proactively monitor regulatory trends and intelligence to identify new product opportunities and potential risks, presenting actionable recommendations to the Wellbeing Collective Operating Companies and International Teams
Set Standards: Set standards and decision-making frameworks for global compliant labeling, claims, and marketing communications. Develop SOPs, define performance metrics, and guide teams on regulatory best practices
International Expansion: Direct and manage regulatory procedures worldwide, including dossier preparation, label development and claims support, and global marketing applications. Provide oversight for preparation and delivery of materials for regulatory agency meetings and inspections
Provides a vision and leadership for Policy and Regulation to assure that appropriate Wellbeing representation in external advocacy activities and industry forums is achieved
Participates in due diligence and provides regulatory advice and perspective on all potential licensing and M&A deals
Brand Portfolio Accountability: Act as the regulatory portfolio owner, ensuring timely and compliant maintenance of the Wellbeing Portfolio
Risk Management: Proactively identify and communicate potential regulatory risks, offering clear mitigation options

What we offer

health insurance (including prescription drug, dental, and vision coverage)
retirement savings benefits
life insurance and disability benefits
parental leave
sick leave
paid vacation and holidays
access to numerous voluntary benefits
bonus eligible
Long-Term Incentive (LTI) eligible

Fulltime

Senior Manager, Hub Labeling

Is responsible for executing the content management of LPDs, LLDs and PLDs for n...

Location

Australia , Sydney

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
Advanced academic qualifications/degree such as PhD
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
Demonstration of attention to detail and problem-solving skills
Proven technical aptitude and ability to quickly learn new software
Proven technical aptitude and ability to quickly learn regulations and standards
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs
Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label

Job Responsibility

Is responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for their assigned products across multiple countries/regions
Acts as a subject matter expert for local labeling throughout the organisation, leading or assisting in the most complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval
Sharing of intelligence and contribution to knowledge resources is also a key part of the role
The Senior Manager is proactive in gathering, assessing and disseminating regulatory intelligence for use by the labeling managers as well as for use in strategic decision-making at the global group level
The Senior Manager will insightfully seek technology solutions leveraging process automation and Artificial Intelligence (AI)
May lead/manage projects
May supervise/lead colleagues/teams
May act as delegate/deputy for the TLs
To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate
To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing

What we offer

Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options

Fulltime

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Business Performance Senior Manager

The Business Performance Senior Manager is a member of the Transformation Execut...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree (scientific area) and 10 years of directly related experience OR Bachelor’s degree (scientific area) and 12 years of directly related experience
Knowledge of Regulatory principles
Working with policies, procedures and SOP’s
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
General knowledge of national legislation and regulations relating to medicinal products
General awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities
Knowledge and experience in the international regulatory environment relevant for product area and development stage
Understanding of drug development
Able to anticipate regulatory Agency questions and potential responses
Demonstrate strong teamwork ability

Job Responsibility

Represent GRAAS at cross-functional MAL and Business Development-related forums, providing strategic input and thought leadership
Form and lead sub-function teams for integration and licensing activities, ensuring alignment with strategic objectives
Drive strategic solutions to complex business problems, leading analyses and negotiations with key decision makers
Lead Regulatory workstreams across all deal phases
Serve as Lead for all product licensing work, including integrations into and transitions out of Amgen
Closely partner with Regulatory Affairs (RA) Therapeutic Area Integration Project Lead and advise/instruct them on end-to-end process and details of planning and execution of acquisition integration
Act as their delegate as needed in cross-functional meetings
Assist with pre-deal close GRAAS due diligence
Develop and manage GRAAS integration workplan
Draft and manage any new controlled documents unique to the integration, such as Quality Integration PLANs and bridging process GDEs

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

New

Associate Commercial Counsel

As an Associate Commercial Counsel, you’ll support the end-to-end contract proce...

Location

Argentina , Buenos Aires

Salary:

Not provided

Dialpad

Expiration Date

Until further notice

Requirements

At least 2-5 years of experience as a commercial attorney
Prior experience working in a sales-driven or fast-paced technology environment (SaaS preferred)
Demonstrated experience working cross-functionally and preferably with sales, finance, and procurement teams
Excellent analytical and problem-solving skills, with an ability to communicate issues in a straightforward and understandable manner
Comfort using and learning AI-powered tools to assist with contract review, legal research, and knowledge management, and a willingness to experiment, provide feedback, and help improve how our legal team works with AI
Fluent in spoken and written English

Job Responsibility

Work closely with other in-house legal team members to manage the contract review process for a variety of customer, partner, and vendor contracts, including SaaS agreements, services agreements, statements of work, vendor agreements, and NDAs, from intake through negotiation and completion
Draft, revise, and negotiate contracts, and provide clear, business-oriented recommendations to internal stakeholders that balance risk and the company’s needs
Review contract modification requests and coordinate with internal business partners to negotiate terms and obtain necessary approvals for non-standard positions
Provide guidance to cross-functional teams on commonly requested edits, non-standard terms, and general contractual questions
Partner with key stakeholders, including Finance, Privacy, and Security, to address contract issues, including privacy/GDPR/CCPA-related clauses
Support the business on legal review for RFPs and a variety of other customer-driven requests
Provide legal support to the Customer Success team on customer relationship management and escalations, helping resolve issues in a constructive, solution-oriented way
Assist with efforts to improve and coordinate continuing education, online resources, and training programs for business partners
Apply original, innovative thinking and continuous improvement to our processes, products, systems, and services to better serve internal customer needs, and be a champion for a better, faster, and simpler way of doing things
Leverage AI-powered legal tools (for example, for first-pass contract review, clause extraction, and legal research) to accelerate your work, while exercising sound legal judgment and escalating complex or high-risk issues to senior counsel as needed

What we offer

Competitive benefits and perks
Robust training program
Inclusive office environment
Vibrant environment to cultivate collaboration and connection
Exceptional culture
Recognized repeatedly as a certified Great Place to Work

New

Restaurant and Bakery Prep Cook

At Perkins Restaurant & Bakery our employees are part of the Perkins extended fa...

Location

United States , Wisconsin Rapids

Salary:

11.00 - 12.50 USD / Hour

Perkins Restaurant & Bakery

Expiration Date

Until further notice

Requirements

Reports to work well-groomed, in clean and proper uniform and at all times practices good person hygiene
Uses, maintains and cleans all kitchen equipment, plus preparation and storage areas
Stocks and rotates products on line to ensure they are within shelf life standards
Has sufficient knowledge of recipes, menu items and prep procedures to ensure correct portioning, quality, cooking time and performance standards
Prepares prep items according to guest request within company standards and following food safety and sanitation procedures
Ensures products are accurately portioned and ensures food products are prepared as specified by recipes
Utilizes FIFO (first in first out) standards when preparing items
Maintains cleanliness of the kitchen, prep areas, coolers and storage areas
Follows proper safety procedures and policies concerning food handling, rotation and storage
Conducts line sweeps throughout the shift

Job Responsibility

Prepares menu items according to company policies, procedures, programs and performance standards
Responsible for helping to maintain food costs and maintain cleanliness of the kitchen at all times
Performs all duties to maximize guest satisfaction and quality of work environment as directed by Kitchen Manager or Manager on Duty

What we offer

Employee discounts
Flexible schedule
Opportunity for advancement
Training & development
Medical, Dental, Vision, Wellness Program, Life Insurance, Disability Insurance
401k, Health Savings Account
Employee Assistance Program, Employee Discount Program, Vacation/Sick Time Benefits, Travel Accident Insurance
Discounted Tuition, Waived Application Fee, Deferred Tuition, Complimentary Course, & More!

Fulltime

New

Systems Engineer - Communication Systems

As Systems Engineer you will design, configure, test, and deliver MoD and Govern...

Location

United Kingdom , Surrey

Salary:

40000.00 - 48000.00 GBP / Year

BLUESTREAM PEOPLE

Expiration Date

Until further notice

Requirements

Strong ownership, problem-solving, and decision-making skills
Understanding of network design and associated technologies
Excellent communication, organisation, and administration skills
Flexible, proactive, and customer-focused approach
Eligible for DV Security Clearance
Degree-level qualification in a relevant discipline or equivalent experience (engineering preferred)
Broad ICT experience
satellite communications desirable
Cisco CCNA (or equivalent) or Juniper certification at a similar level
Professional registration desirable

Job Responsibility

Design and configure systems for MoD/Government projects
Work with the Project Office to deliver assigned tasks to specification
Test, evaluate, and verify new equipment and software
Deliver projects in accordance with agreed specifications
Produce and maintain technical drawings and documentation
Define IP structures and support equipment selection and specifications
Support customer meetings, future projects, and system enhancements
Participate in the MoD/Government engineer duty rota
Provide technical input for proposals and new projects
Deliver training and support trials with MoD/Government agencies

What we offer

Negotiable

Fulltime

Junior Regulatory Affairs Associate

Parexel

Location:
Malaysia , Petaling Jaya

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 05, 2026

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