Job description

Position Overview:

The company is seeking a Senior Regulatory Affairs Specialist for regulatory document preparation and submission to domestic and international health agencies.

Responsibilities:

• Prepares, drafts and tracks regulatory documents, including Investigational New Drug applications (INDs) submission, Annual Reports, and other regulatory documents.
• Develops and maintains annual reports and other regulatory document templates as required by the Health Agencies.
• Researches and communicates scientific and regulatory information in order to write submission documents.
• Prepares, tracks and maintains regulatory submissions, amendments and correspondence with the regulatory authorities.
• Assists in regulatory monitoring and resolution of compliance issues.
• Participates in the preparations of pre-IND meetings, IND, CTA submissions, and drafting marketing applications (NDA, BLA, 510k, PMA, etc.)
• Participates in the preparations of regulatory submissions and agency meetings.
• Participates in scientific team meetings and provides input on regulatory issues regarding regulatory document preparation, regulatory intelligence, and regulatory strategy
• Develops internal procedures and tools.
• Conducts informational or training sessions for stakeholders.
• Performs literature searches, citation and extraction of information to support regulatory documents
• Engages in administrative tasks such as drafting meeting minutes
• Assist with area documentation creation, SOP revisions, and review related to complaint reporting.
• Prepares sponsor/investigator/pharmaceutical company meeting minutes
• Other duties as assigned

Skill Requirements:

• MSc or Ph.D in scientific discipline or related field. Advanced degree is preferred.
• 7+ years of regulatory affairs experience
• Regulatory Affairs Certification (RAC) preferred.
• Must demonstrate experience with drug regulatory process, FDA, EMA or other regulatory agencies
• Must demonstrate experience in drafting, filing, and maintaining applications with FDA and/or EMA, or similar health Agency
• Must demonstrate experience and working knowledge of ICH, GCP and regulatory agency requirements both domestically and internationally
• Must have a high proficiency of written and spoken English.
• Must have proficiency with an office productively suite such as Microsoft Office, SharePoint, Adode, MS Word, Excel, and Outlook
• Demonstrates critical thinking skills and attention to detail
• Excellent communication skills, both written and verbal, and the ability to give and receive honest and direct feedback
• Excellent teamwork and interpersonal skills, with calm demeanor and positive attitude under pressure

Job Type: Full-time

Pay: $57,937.24 - $92,659.57 per year

Benefits:

• Flexible spending account
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Silver Spring, MD: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Master's (Preferred)

Experience:

• IND Submissions: 7 years (Required)
• FDA regulations: 7 years (Required)
• eCTD modules: 7 years (Required)

License/Certification:

• RAC (Preferred)

Work Location: Remote

apartamentosquality.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, apartamentosquality.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, apartamentosquality.com is the ideal place to find your next job.