Global Regulatory Writing – Senior Manager Job at Amgen (Hyderabad)

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

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

Senior Manager, Global Brand Marketing CHC

The Senior Manager, Global Brand Marketing is the global owner of assigned Consu...

Location

Italy , Milano; Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

10+ years of experience in global or regional marketing roles within consumer-centric environments (Consumer Healthcare, FMCG, digital-led consumer brands)
Demonstrated track record in driving digital marketing capability and innovation transformation
Proven experience in brand strategy, consumer activation and innovation development at scale
University degree in Marketing, Business Administration, Economics or equivalent
Strong digital mindset and data fluency
Best-in-class innovation capability (insights, concept writing, design thinking, prototyping)
Ability to translate science and complexity into simple, compelling consumer value
Strategic thinking combined with executional excellence
Strong influence and leadership in matrix organizations
Fluent in English

Job Responsibility

Own and evolve the global brand strategy, ensuring clear positioning, long-term brand ambition and competitive relevance in a modern CHC context
Build and steward distinctive, repeatable brand assets and global creative platforms
Champion digital capability within the global marketing team, driving adoption of digital-first thinking across media, content, consumer journeys and performance measurement
Lead strategic brand planning across short-, mid- and long-term horizons, ensuring continuity between immediate activation and sustainable brand equity building
Elevate innovation quality and ways of working, applying best-in-class approaches to insight generation, concept development, design thinking, visualization and rapid prototyping
Translate complex scientific evidence into clear, motivating and consumer-relevant benefits, ensuring credibility, differentiation and real-world impact
Drive insights-led decision making, integrating qualitative and quantitative data (consumer, shopper, digital, performance) to inform prioritization and activation choices
Define global consumer activation frameworks and journeys, enabling consistent yet flexible execution across channels and touchpoints in diverse markets
Ensure strong two-way alignment with Regions and local markets, combining global direction with local learning and feedback
Operate effectively in a cross-functional matrix, aligning Medical, Regulatory, R&D, Analytics and Commercial teams around shared brand and innovation priorities

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Senior Manager, Regulatory Affairs

Beam is seeking a Sr Manager/Manager Regulatory Affairs to progress a broad port...

Location

United States , Cambridge

Salary:

155000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS in a medical or scientific field required
Strong grasp of drug development lifecycle and strategy
A minimum of 5 years of experience working in Regulatory Affairs
Knowledge of US and global regulatory procedures and practices
Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP)
Experience supporting teams through interactions with Regulatory Agencies and Health Authorities
Ability to develop and maintain collaborative working relationships with internal and external partners
Excellent written/verbal communication skills, attention to detail, organizational skills

Job Responsibility

drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines
Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations
Maintain and update regulatory submission plans, timelines, and other core strategic documents
represent Regulatory Affairs on cross functional and project teams to ensure regulatory input into non-clinical, clinical and commercial strategies
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time

Fulltime

Senior Manager, Global Brand Marketing Consumer Healthcare

The Senior Manager, Global Brand Marketing is the global owner of assigned Consu...

Location

Italy , Milano; Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

10+ years of experience in global or regional marketing roles within consumer-centric environments (Consumer Healthcare, FMCG, digital-led consumer brands)
Demonstrated track record in driving digital marketing capability and innovation transformation
Proven experience in brand strategy, consumer activation and innovation development at scale
University degree in Marketing, Business Administration, Economics or equivalent
Strong digital mindset and data fluency
Best-in-class innovation capability (insights, concept writing, design thinking, prototyping)
Ability to translate science and complexity into simple, compelling consumer value
Strategic thinking combined with executional excellence
Strong influence and leadership in matrix organizations
Fluent in English

Job Responsibility

Own and evolve the global brand strategy, ensuring clear positioning, long-term brand ambition and competitive relevance in a modern CHC context
Build and steward distinctive, repeatable brand assets and global creative platforms
Champion digital capability within the global marketing team, driving adoption of digital-first thinking across media, content, consumer journeys and performance measurement
Lead strategic brand planning across short-, mid- and long-term horizons, ensuring continuity between immediate activation and sustainable brand equity building
Elevate innovation quality and ways of working, applying best-in-class approaches to insight generation, concept development, design thinking, visualization and rapid prototyping
Translate complex scientific evidence into clear, motivating and consumer-relevant benefits, ensuring credibility, differentiation and real-world impact
Drive insights-led decision making, integrating qualitative and quantitative data (consumer, shopper, digital, performance) to inform prioritization and activation choices
Define global consumer activation frameworks and journeys, enabling consistent yet flexible execution across channels and touchpoints in diverse markets
Ensure strong two-way alignment with Regions and local markets, combining global direction with local learning and feedback
Operate effectively in a cross-functional matrix, aligning Medical, Regulatory, R&D, Analytics and Commercial teams around shared brand and innovation priorities

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

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 Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Manager / Senior Manager - Financial Services Consulting - Information Technology

Location

Hong Kong , Hong Kong

Salary:

Not provided

Forvis Mazars

Expiration Date

Until further notice

Requirements

University degree majoring in Finance, Accounting, Business, Legal, Information Systems, Computer Science/ Engineering or related subjects
Minimum 4-5 years’ experience gained in professional services firms, commercial banks or other financial institute experience will be an advantage
Demonstrate good analytical, problem solving and presentation skills. Flexible, self-starter possessing intellectual curiosity. Effective time and project management with excellent interpersonal skills
Keen on career development on any of the following areas: financial services regulatory consulting, compliance, governance and internal controls, risk management, operational / technology risk management, business & system processes review, internal audit, cyber-security and business consulting
Interested in gaining experience in any of the following industries: Banking and capital markets (client on-boarding / KYC / AML / investment product suitability and other regulatory compliance, front office activities in products / sales channels, middle and/or back office control, operational / technology risk management – commercial banking, private banking, investment banking)
Asset management (distribution channels, controls and processes – prime brokerage, fund administration, fund management (retail, institutional, and/or real estate / private equity, etc.))
Digital asset management/ trading (Cybersecurity, custodian management, licensing requirements)
Insurance (underwriting, claims, reserving, Solvency II, policy administration systems – general or life insurance)
Payment industry (Cybersecurity, settlement and clearing)
Ability to identify and assess business process controls and linkage to IT systems

Job Responsibility

Lead a client-centric advisory team in financial services industry
Support the development on consulting engagement plans and project approaches, analyse client’s current business processes and understanding the risk management environment for financial institutions
Support the planning, execution and delivery of consulting engagements covering regulatory, operational and IT advisory with FS clients in areas such as client onboarding, KYC, AML, system architecture/ pre- or post-implementation, reviews
IT regulatory & licensing reviews (e.g. cybersecurity requirements on C-RAF and iCAST requirements, IS guideline, MCRA membership application, etc.)
Utilise your skills in the areas of structured problem solving, business analysis, analytics, design thinking and lean process improvement to help our FS clients drive profitability and performance through their business operations
Use of technology and data including FinTech/ RegTech/ InsuTech innovation with respect to financial institutions to promote innovation and achieve regulatory compliance
Support change management including the revision or formulation of new policies, systems and controls aligned with regulatory requirements and regulators’ expectations
Plan, execute and communicate with engagement stakeholders of the financial institutions
Identify current and emerging trends of regulatory requirements for the financial services sector in Hong Kong, Singapore, Mainland China and other Asian markets and global regulatory expectations

What we offer

medical and dental insurance
life insurance
a 5-day working week
discretionary performance bonus
birthday leave
marriage leave

Fulltime

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