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

Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

This position is responsible for leading CMC regulatory activities for investiga...

Location

United States; Belgium; Italy; United Kingdom , Collegeville; Wavre; Durham; Siena; London; Waltham

Salary:

144375.00 - 240625.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences or related field
Four or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise
Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
Two or more years of experience completing project management tasks.

Job Responsibility

Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements
Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies
Mentors or trains staff
May have direct line management responsibility
Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate
Provides strategic direction, data assessment and conclusions within and across departments
Able to establish organisational networks (internal and external understanding departmental constraints/pressure within a highly complex organisation
Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment)
May deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (PIRCs)
Has accountability for submission content

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation

Fulltime

Sr Associate Regulatory Affairs - CMC

If you feel like you're part of something bigger, it's because you are. At Amgen...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Background in CMC related functions (e.g., Quality, Manufacturing, etc) with limited or no prior Regulatory Affairs experience
Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast-paced learning environment
Developed project management and organizational skills
Strong and effective oral and written communication skills

Job Responsibility

Contribute as a key member of the global regulatory CMC product team
Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select CMC procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Head of Global Regulatory Affairs CMC

This position is responsible for defining and executing global regulatory strate...

Location

Italy , Bologna; Milan; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

15+ years of experience in regulatory affairs with strong focus on CMC
Deep expertise in global CMC regulatory requirements (FDA, EMA, ICH guidelines)
Proven leadership of global teams and complex regulatory programs
Demonstrated success in major filings and global product approvals
Advanced degree in chemistry, pharmacy, chemical engineering, or related scientific discipline (PhD preferred)
Strategic regulatory leadership and decision-making
Deep CMC scientific and technical expertise
Strong understanding of pharmaceutical manufacturing processes
Health authority interactions and relationship management
Proven ability to be hands-on, agile and lead organizational efforts and innovation by example

Job Responsibility

Define and lead global regulatory CMC strategies and execution for development, registration, and post-approval lifecycle management, leveraging frameworks such as RELIANCE where appropriate
Ensure alignment of CMC regulatory approaches with overall product development and commercialization strategies, partnering cross-functionally to ensure aligned approach
Provide strategic input into critical development milestones (e.g., IND/CTA, BLA/NDA, MAA)
Oversee the development of high-quality CMC regulatory dossiers, including Module 3 content and supporting documentation, including rigor in CMC regulatory justifications, control strategies, comparability, and specifications
Ensure alignment with ICH guidelines and evolving regulatory science expectations, proactively communicating these and their impact for Alfasigma across the organization
Lead regulatory support for manufacturing changes, site transfers, scale-ups, and technology transfers
Serve as the senior regulatory CMC representative in interactions with global health authorities (e.g., FDA, EMA)
Establish global frameworks for CMC change management, ensuring compliance and minimizing regulatory risk
Drive efficient handling of complex changes (e.g., process improvements, new technologies, dual sourcing)
Ensure global alignment and consistency across markets

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime