Director, Regulatory Affairs - CMC/Biologics

ICON Clinical Research; Center Square (PA); Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Global EAP LifeWorks

Life assurance

Country-specific benefits

Job summary

ICON Clinical Research is seeking a Director of Regulatory Affairs CMC to oversee regulatory CMC activities for biologics and other complex therapies. The role focuses on development, submissions, and strategic planning across US and global environments.

You will lead technical development, testing, and manufacturing considerations, and coordinate with clients and regulators to secure approvals while supporting post‑approval activities.

Qualifications

• Bachelor's degree in life sciences or related field.
• Advanced degree ( MSc./PhD./MD/PharmD/MBA) may be beneficial.
• Regulatory CMC experience in global environment (US/EU/Canada).
• Technical development, testing and manufacturing knowledge across dosage forms.

Responsibilities

• Serve as a technical expert in development, testing and manufacturing of Biologics and advise ICON colleagues and clients.
• Prepare regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements.
• Lead submissions and negotiations with clients and government agencies to obtain approvals.
• Develop regulatory strategies and share insights with internal teams.
• Provide strategic regulatory advice to clients based on expertise and experience.
• Monitor new regulatory requirements and disseminate key findings.
• Lead or participate in cross-service quotations and manage projects within budget.
• Support US FDA drug listing, establishment registrations, and related activities.
• Act as US Agent for client submissions and liaison with agencies.

Skills

Regulatory affairs

CMC knowledge

Biologics regulatory

Regulatory strategy

US FDA submissions

Education

Bachelor's degree in life sciences

Advanced degree beneficial

Job description

Director, Regulatory Affairs - CMC/Biologics

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Director, Regulatory Affairs CMC

Location

The position may be remote based across the US, or East Coast preferred

The Role

As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.

The department is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance.

We are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience.

Responsibilities

• Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues, and clients providing advice

• Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements

• Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.

• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.

• Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.

• Enthusiastically monitors for new regulatory requirements and shares key findings.

• Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.

• Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports

• Serve as US Agent for client submissions and act as interface with local agency and sponsor

• Support right from preclinical to post approval activities for client submissions.

Education/Experience

• Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.

• Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.

• Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. US, EU, Canada).

• Technical development, testing and manufacturing of wide range of dosage forms

• Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.

• Experience supporting business development activities and people management an asset.

• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)