Regulatory Affairs Consultant III

job summary:
This is a high-impact, 6-month remote contract designed for a Regulatory CMC expert who thrives in a global, cross-functional environment. Whether you are leading the charge on early-stage development or providing critical support for commercial-phase programs, you will serve as the primary global voice for CMC strategy and Health Authority interactions. You will be responsible for authoring and reviewing pivotal submissions-including IND, IMPD, CTA, and MAA documents-while ensuring every deliverable aligns with rigorous global standards.

location: Telecommute
job type: Contract
salary: $75 - 84 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
• Preparation and delivery of CMC Regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs)
• Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
• Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions
• Managing CMC aspects of routine and non-routine Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
• Monitoring changes in the Regulatory CMC environment to support and advise key stakeholders and teams.
• Providing input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy.
• Coordinating and completing regulatory assessments of CMC changes in the designated systems
• Responsible for assuming responsibilities from the Team Lead or Global Regulatory CMC lead, as agreed and delegated and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions.
• Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of Regulatory CMC on cross functional work streams
• Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC standards and SOPs, as assigned.
• Ensure that appropriate records are maintained in the designated system for submission in assigned regions

qualifications:
Required:

• At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC.
• Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities)
• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products
• Experience of direct communication and negotiation with regulatory agencies on CMC matters
• Knowledge of GMP requirements and standard systems (e.g. change management systems)
• Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
• Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy
• Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
• Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
• Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
• Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.

Preferred:

• 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field

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skills: Good Manufacturing Practices (GMP), Investigational New Drug (IND), Marketing Authorization Application (MAA), International Council for Harmonization (ICH), Chemistry Manufacturing and Controls (CMC)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.