Quality Compliance Senior Manager - Labelling & Regulatory Affairs Job at Amgen (Cambridge)

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

Manager, Regulatory Global Labeling

This position will be responsible for leading the development, review, and manag...

Location

United States , San Rafael

Salary:

108000.00 - 162000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD)
2+ years in Regulatory Affairs
Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
US and/or EU Labeling experience minimally required and core labeling experience highly desired
Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
Experience with E2E global labeling processes and management of Company Core Data Sheets
Experience in review process, standards, and industry best practice pertaining to labeling
Strong scientific background and/or experience
Working knowledge of medical terminology and drug safety

Job Responsibility

Lead the development, review, and management of US, EU, and International labeling for a product in development and commercial products
Assess and manage labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages
Ensure appropriate labeling strategies are communicated to project teams
Ensure labeling is compliant with core labeling and local regulations
Ensure labeling is accurate and of the highest quality
Support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status
Lead the assigned product labeling teams (PLTs) and support labeling positions
Collaborate with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams
Prepare labeling content based on source documents such as CSRs, regulatory requirements and other reference documents
Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

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

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

Senior Manager, Regulatory Affairs

The mission of the Regulatory Affairs group is to implement effective processes ...

Location

United States , St Louis

Salary:

122187.50 - 158125.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
7 years of Regulatory Affairs experience
Minimum of 7 years of US EPA Antimicrobial registration experience
US State Registration experience
Leadership experience managing a team of people
Ability to travel as noted above

Job Responsibility

Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compliance requirements for marketing STERIS products in their assigned areas or regions where STERIS does business
Effectively interface with government agencies, notified bodies, consultants and authorized dealer representatives as necessary to address registration related issues. Act as person responsible for regulatory compliance as assigned by upper management
Provide regulatory guidance and support to project teams and STERIS internal Customers to support new product development and existing product lines in support of registration requirements.
Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified.
Gather information and documentation on new or modified products to determine submission requirements for particular markets.
Compile and create document registration packages through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities.
Critically assess the strength and completeness of documentation created by others
advise improvements to comply with current requirements for particular regulatory authorities.
See that all direct team members maintain submission documents and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
Report to management concerning current, pending, and re-registration approvals. Identify and take action on any unexpected delays

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

Manager - Labeling

As part of GLC group, and under the supervision of the Global Labeling Process M...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s/Master’s degree with minimum 8 years of experience in Labeling
Previous experience working in industry in support of End to End Labeling Initiatives including global labeling compliance and regional labeling for international (ROW) markets
Oral and Written Communication and Presentation Skills
Project Management skills such that candidate can work independently to deliver expected outputs
Relationship Management
Influencing, Negotiation and Decision Making Skills
Extends capabilities by working closely with senior staff/experts within and outside the internal organization
Previous labelling experience in HA Regulations and International Markets
Knowledge of labelling regulations and requirements, industry trends and business principles
Demonstrates leadership attributes, managing individual and complex group projects

Job Responsibility

Apply expert labeling knowledge to collaborate with Local Amgen Affiliates, along with Regional Regulatory Affairs and Operations colleagues, to plan and implement label changes, ensuring compliance with labeling processes
Provide process and system support
Provide artwork source text and process support as necessary
Participate in Labeling Submissions meetings to provide input on labeling processes
Provide regional operational support for labeling
Support document management of all regional labeling documents, source text, illustrations, and related documents
Support the maintenance of business process documentation, including guidance documents
Provide accurate regulatory assessments for Change Control records governing the implementation of labeling changes
Maintain a state of inspection readiness for records within the Labeling tool
Develop regional package component labels according to regulations and company guidelines

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 – 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

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Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Job Responsibility

Requirements

What we offer

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