Regulatory Compliance Associates® Inc. (RCA), A Nelson Labs company, provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges. We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing.

The Position: RCA is seeking a Regulatory Affairs Subject Matter Expert (SME) to support projects within our pharmaceutical practice. This position can be supported remotely.

Job Description

The Regulatory Affairs SME will be responsible for developing strategies and establishing policies according to business and client needs, both domestically and internationally. This position will provide direction and oversight to projects, advise clients on regulatory strategies, and submit final documentation to the FDA and/or other global regulatory agencies. Additionally, the role includes management of project teams supporting regulatory filings for the FDA, Health Canada, and the EMA (including electronic filings with FDA).

Job Duties and Responsibilities

• Participate in client scoping calls.
• In depth understanding of regulations, policies, or procedures.
• Prepare and submit requests for pre-submission meetings.
• Prepare and submit the required regulatory documentation for FDA pharmaceutical submissions (IND/CTA, NDA/BLA/MAA).
• Assess the regulatory impact of changes to existing products.
• Determine the appropriate regulatory pathway for the required regulatory submissions or internal documentation required.
• Interaction with the FDA and/or other global regulatory agencies on behalf of a client.
• Ensure regulatory filings are compliant with FDA guidelines and/or other global regulatory agencies.
• Advise clients on regulatory requirements for development plans, study designs and marketing approval.
• Provide technical review of data or reports and provide feedback regarding areas of concern.
• Conduct risk assessments and manage critical issues / regulatory body interactions.

Qualifications:

• Regulatory experience in at least one major geographic area required, with prior global regulatory exposure.
• Knowledge of global pharmaceutical regulations and standards, product registration, clinical investigation, and the product clearance/approval processes.
• Demonstrated ability to handle multiple projects with shifting priorities, excellent written and verbal communication skills, and ability to work in thrive in a multi-cultural environment.
• Ability to work flexible hours to accommodate meetings and teleconferences in different time zones.
• A minimum of a bachelor’s degree or equivalent in a life science or health related discipline, with 5+ years of experience in the pharmaceutical industry.

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Nelson Labs takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. 

VEVRAA Federal Contractor