Regulatory Affairs Manager (CMC) Job at Amgen (Hyderabad)

Senior Global CMC Manager (Development & Lifecycle)

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Sciences
Strong understanding of regulatory requirements and applicable legal frameworks for pharmaceutical products
Proven CMC expertise covering the full product lifecycle, including post-approval development and manufacturing-related changes
Extensive experience in variation management, including the development and execution of regulatory and CMC strategies
Experience with EU regulatory procedures (primarily national, as well as DCP and MRP), with exposure to additional markets considered an advantage
Demonstrated experience working at the interface between Regulatory CMC, R&D CMC, and Manufacturing for commercialised pharmaceutical products
Hands-on experience with CMC Module 3 authoring, review, and lifecycle maintenance
Solid understanding of pharmaceutical manufacturing processes, formulation principles, APIs, and CMO-based supply models
Proven ability to work cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Commercial functions, and external partners
Experience interacting with regulatory authorities and maintaining effective professional relationships

Job Responsibility

Act as global CMC Module 3 owner throughout the product lifecycle, ensuring scientific consistency and alignment with the actual manufacturing processes, formulation, APIs, control strategies, and implemented post-approval changes
Manage and maintain the CMC (Module 3) components of global and local dossiers, including technical preparation and compilation of CMC documentation to support regulatory submissions and lifecycle maintenance, with particular responsibility for legacy products
Ensure timely implementation of approved CMC changes within defined scope, including verification that Module 3 documentation and internal systems reflect Health Authority approvals
Assess and lead regulatory CMC evaluation of proposed changes, including technical impact assessment, variation classification, and identification of required documentation in alignment with applicable EU and relevant market requirements
Review and approve regulatory CMC documentation for submissions and lifecycle changes in compliance with applicable regulatory requirements and internal regulatory information and document management systems
Initiate and maintain CMC-related regulatory events and documentation within the regulatory information management system (e.g., Veeva RIM) in accordance with internal procedures
Maintain a current understanding of relevant CMC-related regulations, guidelines, and standards, as well as established and emerging manufacturing and development practices applicable to commercialised pharmaceutical products
Lead CMC strategy development for assigned products across development and lifecycle phases, providing aligned CMC input to regulatory strategy discussions, technical risk assessments, gap analyses, and the evaluation and implementation of lifecycle changes
Apply in-depth knowledge of CMC Module 3 as a practical lifecycle tool to support and drive technical and regulatory decision-making related to manufacturing and post-approval development activities
Act as a technical and regulatory CMC counterpart towards manufacturing CMOs, developing a sound understanding of their manufacturing operations and providing appropriate scientific input, guidance, and challenge as required

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, hybrid model with the primary work place in the office, 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 dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Regulatory CMC Project Manager

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management)
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls)
Strong project management skills with a track record of managing complex projects and meeting deadlines
Excellent organizational and communication skills
Excellent time management abilities
Proficient in Microsoft Office Suite
Proven experience with project management software ie. Smartsheet
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones

Job Responsibility

Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions
Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements
Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed
Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards
Health Authority Engagement: Support the preparation of materials for health authority engagements

What we offer

Flexibility of working remotely
Part of a supportive and dynamic team
Supportive and inclusive environment
Opportunities for career growth
Flexible work arrangements
Diverse and global client exposure
Learn from experts

Director of RA CMC

About company: A pre-IPO biotech

Location

China , Shanghai

Salary:

1000000.00 - 1400000.00 CNY / Year

Randstad

Expiration Date

June 03, 2026

Requirements

Advanced degree (Ph.D. preferred, M.S. required) in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field
Minimum of 10 years of combined experience in CMC development (process, analytical, formulation) and Regulatory Affairs CMC within the pharmaceutical industry
Experience with device-drug combination products is a plus
Proven track record of successfully developing and implementing global CMC regulatory strategies from Phase 1 through approval
Extensive experience authoring CMC sections for major filings (IND/NDA) and leading health authority interactions
Comprehensive knowledge of US, EU, and ICH CMC guidelines
Must understand the scientific and technical nuances of oligonucleotide synthesis, purification, analytics, and stability
Outstanding written and verbal communication skills in English are mandatory
Demonstrated ability to think strategically, anticipate regulatory challenges, and develop innovative solutions
Strong leadership presence with the ability to influence and align cross-functional teams without direct authority

Job Responsibility

Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval
Regulatory Submission Leadership: Serve as the Regulatory CMC Lead for major filings. Author, review, and critically assess high-quality CMC sections for all global regulatory submissions
Health Authority Interactions: Lead the preparation, coordination, and execution of all CMC-focused interactions with global health authorities
Expert Guidance on Complex Products: Act as the in-house subject matter expert on global regulatory CMC requirements for complex oligonucleotide-based products, including device-drug combination products
Strategic Liaison & Collaboration: Serve as the primary regulatory liaison between the CMC department and the broader Regulatory Affairs team

Fulltime

Regulatory Project Manager

At GSK, we’re constantly developing new products and improving our established m...

Location

Poland , Poznan; Warsaw

Salary:

236250.00 - 393750.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework
Exceptional flexibility, analytical thinking and growth mindset
Excellent interpersonal skills
including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
English writing skills
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness)

Job Responsibility

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers)
Identify risks associated with submission data and information package
and support the development of mitigation strategies
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions

What we offer

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

Fulltime

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
Thorough understanding of Health Canada, FDA, and EMA regulations
Ability to efficiently oversee independent contractors and vendors
Skilled regulatory writer with effective oral communication skills
Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
About 12 years of relevant work experience

Job Responsibility

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
Overseeing the preparation of responses to regulatory authority queries
Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Regulatory Affairs Consultant

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics
Strategic and proactive mindset with strong operational execution
Excellent analytical, problem-solving, and negotiation skills
Effective communicator with strong interpersonal, presentation, and leadership abilities
Ability to manage multiple projects independently in a matrixed, multicultural environment
Proficiency in Microsoft Office Suite and regulatory systems
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred

Job Responsibility

Provide regulatory strategy input for small molecule and biologic products
Support regulatory leads in developing contingency plans for CMC-related scenarios
Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
Partner with manufacturing, quality, and external organizations to address CMC-related issues
Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
Support planning and execution of Health Authority meetings, including mock sessions
Identify and implement process improvements to enhance regulatory efficiency and readiness
Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Fulltime

Director, CMC Regulatory Affairs

Reporting to the Vice President, CMC Regulatory, the Director of Regulatory Affa...

Location

United States , Waltham

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years regulatory CMC experience, including experience as a regulatory CMC product lead, or equivalent industry experience
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams
Able to work independently and complete projects with minimal oversight, escalating issues to regulatory management with discretion
Self-starter and results-oriented individual with outstanding work ethic
must be able to perform in a fast-paced environment
Demonstrates leadership, problem-solving ability, attention to detail, flexibility, and values teamwork
Exercises good judgement in elevating and communicating actual or potential issues to line management
Ability to multi-task and adjust priorities quickly while working under tight deadlines
Experience using electronic document management systems and document review tools

Job Responsibility

Responsible for one or more product(s) and supports the regulatory CMC team in the development & execution of global regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities
Define CMC content (data and documentation) requirements for regulatory submissions and conformance with established requirements
Leads CMC preparation activities for meetings with Health Authorities on CMC related matters
Ensure timely preparation of CMC documents and responsible for handing off submission ready documents for regulatory submissions
Contribute to the evaluation of change proposals for global regulatory impact and support planned global variations and amendments
Identify and communicate critical topics and risk promptly to the regulatory CMC team
Oversee the copyediting, finalization, approval, and hand-off of documents for publishing

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Regulatory Affairs Manager (CMC)

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
May 13, 2026

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