Regulatory Affairs Associate Manager

24 Apr, 2022

Jobs

Regulatory Affairs Associate Manager

Sebela Pharmaceuticals
Braintree, MA
SUMMARY
Participates in the preparation, writing and review of information necessary for filing/maintaining applications pertaining to the regulation process for products requiring governmental approval.
PRINCIPAL DUTIES AND RESPONSIBILITIES
  • Familiar with standard concepts, practices, and procedures within a particular field.
  • Develop and contribute to the content and format for regulatory submissions and related supplements and amendments
  • Strong understanding of FDA processes, guidelines, and requirements
  • Relies on experience and judgment to plan and accomplish goals
  • Reviews and monitors complaint and adverse event reports
  • Performs a variety of tasks as identified by management
  • Works with cross functional groups to collect information necessary for regulatory filings
  • The person must interact with all levels of site management (Vice Presidents to supervisory levels)
  • Works under general supervision. Must have ability to work both independently and within a team in a fast-paced environment to achieve business objectives.
  • Must be able to recognize issues that should be brought to management
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have knowledge and experience in cGMP, cGCP, and FDA requirements. The requirements listed below are representative of the knowledge, skills and/or abilities required.
  • Requires minimum of bachelor’s degree in a scientific field and at least 5 – 7 years of direct experience in the field
  • Excellent English oral and written communication skills
  • Excellent organizational skills
  • Previous experience in the preparation of Investigation New Drug (IND) and New Drug Application (NDA), supportive amendments or supplements, and required reports
  • Familiarity with Code of Federal Regulations (CFR) parts 211 and 312, and 314
  • Strong experience with CTD format and content regulatory filings
WORK ENVIRONMENT
The work environment described here are representative of those an employee encounters while performing the essential function of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will be in an office environment.
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is regularly required to sit for long periods of time. The employee is occasionally required to stand, walk, stoop, kneel, or crouch. The employee must frequently lift and/or move up to 10 pounds.
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Job posted: 2022-04-24