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 independently and 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.
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 on new product development teams and cross-functional initiatives to deliver all assigned regulatory milestones on a timely basis.
- 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 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, high attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
- Strong interpersonal, oral, and written communication skills with professional English proficiency.
Additional Information- Location: Rahway, NJ.
- Work Model: Hybrid structure requiring 3 days onsite and 2 days working from home (Tuesday and Wednesday serve as mandatory core onsite days).
- Global Regulatory Scope: Applies international regulatory guidelines, including FDA-CVM, EMA, and VICH, across both new product development and commercial lifecycle management.
