Director, Regulatory Affairs - CMC/Biologics

Regulatory Jobs; Center Square (PA); Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing programs

Retirement and pension plans

Life assurance and disability coverage

Learning and development opportunities

Job summary

ICON is seeking a Director in Regulatory Affairs CMC to provide expert knowledge on the development, testing, and manufacturing of biologics and small molecules. You will lead regulatory CMC strategies and manage global submission activities across INDs/NDAs/BLAs.

You will interface with clients and government agencies, develop regulatory programs, and oversee project budgets while supporting preclinical to post-approval activities.

Qualifications

• Experience in technical development, testing and manufacturing of biologics and small molecules.
• Ability to develop regulatory CMC strategies for global markets.
• Experience preparing regulatory CMC submissions for INDs/NDAs/BLAs and post-approval Supplements.
• Strong communication and negotiation skills with clients and regulatory authorities.

Responsibilities

• Serve as technical expert in development, testing and manufacturing of Biologics.
• Lead or contribute to regulatory CMC submissions for various regulatory pathways.
• Advise clients with regulatory strategies based on deep CMC expertise.
• Monitor new regulatory requirements and share key regulatory insights.
• Coordinate quotations and manage projects within budget.

Skills

Biologics CMC regulatory experience

Regulatory strategy development

IND/NDA/BLAs submissions

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree beneficial (MSc/PhD/M.D./Pharm.D.)

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.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.