Regulatory Affairs Manager / Senior Manager – Drug Products (REMOTE in EAST COAST)

Position Summary

We are seeking an experienced Regulatory Affairs professional (Manager or Senior Manager level, depending on qualifications) to join our consulting team and provide hands-on regulatory support, client guidance, and strategic input for global drug product submissions.

As part of a CRO/consulting organization, this role offers a broad variety of work across different clients and therapeutic areas. The right candidate will be comfortable moving between new product development and life cycle management projects, adapting to client needs, and serving as a trusted partner. While there will be opportunities to author and review regulatory submissions, this role is not limited to submission writing. Instead, success in this position comes from being flexible, collaborative, and able to guide both internal teams and clients through complex regulatory requirements.

Key Responsibilities

• Lead and contribute to the preparation, review, and submission of regulatory filings to FDA, EMA, and other authorities.

• Provide hands-on support for regulatory document authoring and compiling, balanced with broader strategic and operational guidance.

• Serve as a primary regulatory contact for clients, offering practical solutions for both development-stage and marketed products.

• Collaborate with global regulatory experts, technical teams, and clients to ensure aligned strategies and timely execution.

• Advise on regulatory requirements, risks, and timelines, helping clients navigate evolving regulatory landscapes.

• Support preparation for and participation in regulatory authority meetings.

• Mentor junior regulatory staff and share best practices across the consulting team.

Qualifications

• Bachelor’s or advanced degree in a scientific or related discipline.

• 10+ years of Regulatory Affairs experience in the pharmaceutical industry, with significant exposure to both US and EU drug product submissions (INDs, NDAs/MAAs, variations, supplements).

• Strong understanding of regulatory requirements for drug development and life cycle management.

• Proven ability to work directly with clients, translating regulatory requirements into actionable plans.

• Demonstrated balance of hands-on submission support and strategic regulatory guidance.

• Excellent communication, collaboration, and problem-solving skills.

Preferred Skills & Attributes

• Experience working in a CRO, consulting, or client-facing environment.

• Ability to thrive in a role where no two projects are the same, adapting to varied client needs and priorities.

• Willingness to “roll up sleeves” while also providing big-picture guidance.

• Strong organizational and time management skills to handle multiple client engagements.

• Experience interacting directly with Health Authorizes such as FDA and EMA.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Regulatory Affairs, Regulatory strategy, Regulatory submissions, IND/NDA submissions, pharmaceuticals, CRO.

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