PharmaLex · 1 week ago
Regulatory Affairs Senior Specialist
United States
Full-time
Remote
Mid, Senior Level
3+ years expPharmaLex is a leading service provider for the Pharmaceutical Industry globally, specializing in drug and medical device approval. The Regulatory Affairs Senior Specialist will manage the preparation and submission of regulatory applications, provide expertise on regulatory strategy, and maintain relationships with clients and regulatory authorities.
BiotechnologyConsultingHealth CareMedicalPharmaceutical
Responsibilities
Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients
Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications
Drafts and manages regulatory submissions
Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files
Coordinates regulatory fee payments on behalf of client
Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence)
Liaises with regulatory authorities on behalf of clients (e.g., US Agent)
Builds, develops and maintains working relationships with clients
Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner
Performs basic document management tasks including file transfer, storage, tracking, and archival
Maintains familiarity with current global regulatory submission standards as well as departmental procedures
Other duties as assigned
Qualification
Required
Bachelor's Degree and 3-5 years' experience in Regulatory Affairs; or equivalent combination of education and experience
Experience working in the pharmaceutical industry
Ability to prioritize and drive multiple projects
Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope
Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines
Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA
Ability to maintain confidentiality and responsive to client needs
Ability to adapt under regularly changing conditions
Outstanding organization, analytical, and problem-solving skills
Excellent written, verbal and presentation communication skills
High attention to detail
Technical writing capabilities
Experience in Microsoft Office as well as regulatory systems (e.g., document management systems, RIM systems etc.)
Benefits
Medical, dental, and vision care
Backup dependent care
Adoption assistance
Infertility coverage
Family building support
Behavioral health solutions
Paid parental leave
Paid caregiver leave
Variety of training programs
Professional development resources
Opportunities to participate in mentorship programs
Employee resource groups
Volunteer activities
Company
PharmaLex
PharmaLex provides specialized services for the pharma, biotech, and medtech industries.
1001-5000 employees
H1B Sponsorship
PharmaLex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (7)
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2022-09-12Acquired
Recent News
2025-10-31
2025-08-19
Company data provided by crunchbase