Join our journey of innovation

Regulatory Affairs Intern (Unpaid Internship – 3 Months)

Company: Sigma Molecules
Location: Remote / Hybrid (as applicable)
Duration: 3 Months (with potential extension based on performance and business needs)

About Sigma Molecules

Sigma Molecules is a science-driven consulting organization focused on regulatory strategy, compliance, and CMC excellence across pharmaceutical and biotechnology sectors. We work at the intersection of science, regulation, and innovation to support product development and lifecycle management.

Position Overview

Sigma Molecules is seeking highly motivated Regulatory Affairs Interns with a strong educational or research background to support regulatory strategy and documentation initiatives. This internship is ideal for individuals pursuing or recently completing a Master's degree in Regulatory Affairs or a closely related discipline who are looking to gain hands-on exposure to regulatory operations, CMC strategy, and global submission processes.

This is an unpaid internship for 3 months, with the possibility of extension based on performance and organizational needs.

Eligibility Requirements

• Currently pursuing a Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, Life Sciences, Biotechnology, or related field, OR a recent graduate (within 12 months).

• For current students, formal approval from the university to participate in the internship program is required.

• Prior exposure or experience in Regulatory Affairs (internship, co-op, academic research, or industry experience) is strongly preferred.

• Strong academic foundation in pharmaceutical development, CMC, quality systems, or regulatory science.

Key Responsibilities

• Assist in preparation and review of regulatory documents (e.g., Module 2 & 3 summaries, briefing documents, responses to agency queries.

• Support compilation of regulatory submissions (IND, NDA, ANDA, BLA, variations, amendments, etc.).

• Conduct regulatory intelligence research and analyze guidance documents (FDA, EMA, ICH, and other global agencies).

• Assist in gap assessments for CMC documentation and quality systems.

• Support tracking of submission timelines and internal regulatory processes.

• Contribute to cross-functional coordination activities under supervision.

• Maintain organized documentation aligned with regulatory standards and compliance expectations.

Preferred Qualifications & Industry-Aligned Competencies

• Understanding of global regulatory frameworks (FDA, EMA, ICH guidelines).

• Familiarity with CMC documentation, GMP requirements, and lifecycle management principles.

• Knowledge of submission formats (eCTD structure and regulatory modules).

• Ability to interpret regulatory guidance and translate into actionable strategies.

• Strong analytical and scientific writing skills.

• Detail-oriented with the ability to manage multiple tasks under tight deadlines.

• Superior verbal and written communication skills.

• Strong time management and organizational skills.

• Demonstrated ability to work cross-functionally and in structured regulatory environments.

• Proactive mindset with eagerness to learn and contribute meaningfully.

• High level of professionalism, confidentiality, and ethical integrity.

What You Will Gain

• Real-world exposure to regulatory strategy and CMC consulting.

• Mentorship from experienced regulatory professionals.

• Hands-on experience in submission documentation and regulatory intelligence.

• Opportunity to build industry-relevant skills in a fast-paced regulatory environment.

• Potential extension opportunity based on performance.

How to Apply

Interested candidates should submit the following to sonalm@sigma-molecules.com:

• Updated resume

• Brief statement of interest (1 page max)

• University approval letter (if currently enrolled)

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Sigma Molecules is committed to fostering an inclusive and intellectually rigorous learning environment for future regulatory professionals.