Senior Specialist, Regulatory Affairs

WorkLlama, Inc.; Rahway (NJ); On-site; USD 100,000 - 150,000; Full time

Job summary

WorkLlama, Inc. is seeking a Senior Regulatory Specialist focused on CMC strategies and global submissions. The role requires coordinating across cross-functional teams to prepare, review, and manage dossiers, renewals, and agency responses to support registrations and maintain products globally.

The candidate will analyze post-approval changes, establish timelines, and mitigate risks while contributing to new product development efforts and ensuring compliance with evolving regulatory standards.

Qualifications

• Bachelor's degree in science, engineering or related field; advanced degree preferred.
• Minimum 2 years of pharmaceutical R&D, manufacturing, or quality assurance experience.
• CMC experience strongly preferred.
• Strong written and spoken English communication skills.

Responsibilities

• Prepare and manage regulatory CMC dossiers, annual reports, renewals, and health authority responses to maintain global registrations.
• Assess post-approval changes and establish filing strategies and timelines with risk mitigation.
• Participate in cross-functional teams to meet regulatory milestones on time.
• Maintain regulatory data in compliance with internal processes and global standards.
• Stay current on CMC regulations and agency expectations (FDA-CVM, EMA, VICH).
• Identify regulatory risks and escalate for timely resolution.

Skills

Regulatory strategy

Cross-functional collaboration

Communication

Leadership

Education

BS in science/engineering

Job description

The Senior Specialist plays a critical role in developing CMC regulatory submission strategies and establishing timelines for assigned pharmaceutical products in accordance with global regulations and guidance. Working collaboratively across cross-functional teams, this position oversees the preparation, review, and management of regulatory CMC dossiers, renewals, annual reports, variations, and agency responses to gain new registrations and maintain existing commercial products globally.

Responsibilities

• Manage and prepare regulatory CMC dossiers, annual reports, renewals, supplements/variations, and responses to health authority queries to maintain global product registrations.
• Assess post-approval changes, establish regulatory filing strategies and timelines, identify potential risks, and propose effective mitigation strategies.
• Actively participate in new product development teams and cross-functional initiatives to deliver all assigned regulatory milestones on time.
• Maintain comprehensive regulatory data in full compliance with internal processes, procedures, and global standards.
• Continuously build and share expertise on CMC-related regulations, guidelines (e.g., FDA-CVM, EMA, VICH), agency expectations, and evolving industry standards.
• Proactively identify and communicate potential regulatory issues to management to ensure timely resolution.
• Execute additional regulatory tasks and support ad-hoc operational initiatives as requested by management.

Education

• Bachelor of Science degree (minimum) in science, engineering, or a related field (advanced degree preferred).

Experience

• Minimum of 2 years of relevant experience in pharmaceutical research, manufacturing, or quality assurance.
• Previous experience with Chemistry, Manufacturing, and Controls (CMC) is strongly preferred.
• Proven proficiency in reviewing scientific information and a strong understanding of manufacturing, testing, and quality assurance processes.
• Demonstrated leadership, problem-solving skills, sound judgment, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
• Strong oral and written communication skills with professional English proficiency.

Additional Information

• Global Regulatory Standards: Involves direct application of international regulatory guidelines including FDA-CVM, EMA, and VICH.
• Scope of Role: Covers both new product development programs and commercial lifecycle product maintenance.