Job description

Sr. Specialists, Regulatory Affairs

Berkeley Heights, NJ

Overview

Serve as a Senior Regulatory Affairs Associate for regulatory activities of R&D and/or lifecycle submissions to the U.S. FDA, including, but not limited to the compilation, review, and submission of pre-approval (R&D) and/or post-approval (lifecycle) submissions, such as original applications, amendments & deficiency responses, annual reports, supplements, supplement deficiency responses, and general correspondence for all regulatory submissions with a focus on Chemistry, Manufacturing, and Controls (“CMC”) and Labeling.

Responsibilities

Provide support in applicable team meetings, when consulted, and regarding regulatory guidance/regulations and strategies to other members of the regulatory department, as well as to other departments. Compile, review, and submit applications, amendments, and/or lifecycle changes (focus on CMC and Labeling) for the U.S. market. Submit regulatory filings, such as annual reports, supplements, and amendments for ANDAs and NDAs, which will be submitted to the U.S. FDA to support the business and comply with all FDA requirements. Review change controls for regulatory impact and documentation to be included in regulatory submissions (i.e. batch records, specifications, and analytical methods). Work closely with cross-functional departments (i.e. Quality Assurance, Quality Control, Technical Services, Product Development, Analytical Development, and Project Management) to provide the appropriate regulatory requirements/guidance, as applicable. Support cross functional teams for applicable submissions to the U.S. FDA. Review peer submissions to ensure submission quality and compliance within current guidance and regulations. Keep abreast of emerging regulatory guidance and industry expectations and standards and demonstrate the ability to translate these into process improvements or best practices. Proactively look for ways to improve current processes within the department and across the business to gain efficiency and quality submissions to the U.S. FDA.

Qualifications

Must have a bachelor’s degree in chemistry, biology, pharmacy, health sciences, a related scientific discipline, or the equivalent and five years of progressive post-baccalaureate pharmaceutical experience including 1) regulatory submission experience 2) pre-approval and/or post-approval submissions for the US Market and 3) FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to generic drug products. Alternatively, must have a master’s degree in chemistry, biology, pharmacy, health sciences, a related scientific discipline, or the equivalent and three years of progressive post-baccalaureate pharmaceutical experience including 1) regulatory submission experience 2) pre-approval and/or post-approval submissions for the US Market and 3) FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to generic drug products. Domestic travel up to four times a year to Hikma’s Columbus, OH facility to support business needs. Job can be performed remotely within the 48 mainland states in the U.S.

Those interested in this position, please contact M. Benemar atmbenemar@hikma. com.

Job Type: Full-time

Pay: $110,926.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Work Location: Remote

gatheringourvoice.org 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, gatheringourvoice.org 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, gatheringourvoice.org is the ideal place to find your next job.