CMC Regulatory Consultant Job at CK Group (Munich)

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of vaccines or biological processes - must
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

Flexible work arrangements

Fulltime

Senior Director/Principal Consultant (Regulatory Strategy)

ProductLife Group is a global consulting and outsourcing partner to the life sci...

Location

United States

Salary:

180000.00 - 250000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field)
15+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry
Proven senior-level experience leading regulatory strategy and execution for development-stage programs
Significant, hands-on Health Authority interaction experience, including Health Canada
Experience managing programs from early development through registration-enabling stages
Independent development of FDA and Health Canada regulatory strategies
Authoring and oversight of regulatory submissions and Health Authority meeting packages
Direct experience representing sponsors in formal regulatory meetings
Strong knowledge of ICH guidelines, FDA guidance, Health Canada guidance, and global regulatory frameworks
Cross-functional regulatory leadership across Clinical, CMC, and Nonclinical disciplines

Job Responsibility

Lead regulatory strategy and execution for U.S. FDA and Health Canada development programs
Provide senior-level regulatory guidance for pre-clinical through late-stage development programs
Develop regulatory assessments, integrated development plans, and strategic documentation
Lead preparation and oversight of Health Authority meeting packages, special designation requests, and regulatory submissions (including IND-enabling and CTA-related documentation)
Serve as Authorized Sponsor Representative, including leading and participating in formal FDA and Health Canada meetings
Provide meeting strategy, preparation, and coaching to clients
Act as regulatory project lead for complex, cross-functional programs
Coordinate regulatory activities across Clinical, CMC, and Nonclinical functions
Own project timelines, track progress, and proactively identify and mitigate regulatory risks
Communicate clear regulatory status and recommendations to clients and internal teams

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

New

Senior Regulatory Affairs Consultant

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive experience in managing new registrations, life cycle maintenance, and renewals for biological products including vaccines, recombinant proteins, monoclonal antibodies, and plasma‑derived therapies across major markets such as the US, EU, Japan, Canada, Switzerland and Australia
Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective
Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries
Strong communication and collaboration skills, ability to work independently
The role is for a team lead with expectations to guide/mentor team members on technical aspects including regulatory filings to global markets
Experience level: 10 to 14 years of relevant experience
Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Regulatory Affairs Consultant

Join our team and start a new adventure in an international and dynamic environm...

Location

Italy , Latina

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Experience in regulatory affairs with a focus on CMC for sterile pharmaceutical products
Experience in Quality Assurance, specifically in sterility assurance
Experience with Biotech products and API manufacturing is a plus
Experience in preparing and submitting CTD dossiers for the US market (BLA), minimum 10 years
Experience in international registrations (non-CTD) and GMP Clearances/PMF for Asia and Africa markets
Academic background: scientific degree (e.g., Pharmacy, Chemistry, Biology) preferred
Fluent English and Italian
You demonstrate strong analytical and communication skills

Job Responsibility

Prepare and review regulatory dossiers in CTD format for the US market (BLA)
Manage regulatory submissions and communications for sterile products, including Biotech and API manufacturing
Oversee international product registrations, including non-CTD formats and GMP Clearances/PMF for Asia and Africa markets
Ensure compliance with global regulatory requirements for sterile pharmaceutical products
Collaborate with Quality Assurance teams, focusing on sterility assurance
Support regulatory strategy development for new and existing products
Liaise with cross-functional teams to gather and validate documentation for regulatory submissions
Monitor and interpret changes in regulatory guidelines impacting sterile and biotech products

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support

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

Senior Manager – Drug Substance Technology & Engineering

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Thousand Oaks

Salary:

148715.15 - 201202.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience
Master's degree and 6 years of biologics process development or commercial-scale technical support experience
Bachelor's degree and 8 years of biologics process development or commercial-scale technical support experience
Associate's degree and 10 years of biologics process development or commercial-scale technical support experience
High school diploma / GED and 12 years of biologics process development or commercial-scale technical support experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Support the development, scale-up, tech transfer and manufacturing execution of cGMP clinical and commercial downstream purification processes including, but not limited to harvest, clarification, chromatography (Protein A, AEX, CEX, etc), viral filtration, UF/DF, and sterile filtration
Apply engineering principles and statistical analysis in order to: Identify, develop and implement downstream process improvements into the manufacturing facility
Resolve technical issues observed during scale-up and/or manufacturing execution of purification processes
Manage escalation and on the floor support as required to achieve successful scale-up and manufacturing objectives
Interface with process development teams to ensure processes are robust and are designed to deliver all quality attributes and enable manufacturing success
Collaborate with Process Development, Quality, Manufacturing, Regulatory, Validation and Supply Chain to drive continuous improvements into our business processes
Lead site activities for continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
Ensure safety and compliance of process development activities
Collaborate with other site-functions and network drug substance teams in delivering plant goals
Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives

Fulltime

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CMC Regulatory Consultant

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