Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Alabama, +42 more locations.

📋 Description

• Author and/or review and manage the development of eCTDs for drug submissions to both US and international Health Authorities.

• Assist in the regulatory strategy for drug development initiatives.

• Ensure adherence to the conditions of approval for NDAs, ANDAs, MAAs, and NDSs.

• Oversee and conduct risk management evaluations throughout the product life cycles.

• Engage in internal change management processes, including engineering and documentation change control, as well as cross-functional project meetings.

• Identify the most effective scientific and technical paths and regulatory filing options, such as PAS, CBE, or AR in the US.

• Provide expertise on regulatory requirements for manufacturing sites, Cardinal Health facilities, contract manufacturing organizations, and contract laboratories.

• Manage interactions with regulatory agencies, including both on-site and remote meetings and inspections.

• Represent the company as needed.

• Offer regulatory affairs insights within program/project teams.

• Participate in and advocate for Regulatory Affairs in cross-functional teams and meetings with manufacturing and testing vendors.

• Manage intricate projects with a substantial and enduring impact.

• Contribute to the development of policies and procedures.

• Suggest new practices, processes, metrics, or models.

• Independently determine methodologies for executing new projects.

• Mentor junior colleagues.

⛳️ Requirements

• A minimum of 7 years of hands-on experience in regulatory affairs within the pharmaceutical (drug and/or biologic) sector is essential.

• Experience in managing and authoring eCTD submissions for INDs, NDAs, ANDAs, MAAs, and DMFs.

• Proven background in regulatory strategy development, risk management, and participation in change control processes.

• A Bachelor's degree or equivalent experience in a scientific or regulatory field is preferred.

• An advanced degree is desirable.

• Documented experience interfacing directly with Health Authorities through various means (in-person, teleconferences, and emails).

• Strong understanding of regulatory and cGMP requirements, including 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant 21 CFR parts and regulatory guidance documents.

• Previous experience with European drug applications (NA, MRP, DP, CP) is highly preferred.

• Familiarity with regulatory requirements pertaining to radiopharmaceuticals is preferred.

• Knowledge of nuclear product development and injectable drug products is desirable.

• Exceptional verbal and written communication skills, including the ability to author technical documents and correspond with regulators, as well as to develop and deliver effective presentations.

• Proficient in Microsoft Office applications and software used for managing drug applications.

• Demonstrated diplomacy and negotiation abilities, along with the confidence to make difficult decisions.

• Capability to work autonomously and collaboratively as part of a team.

• Occasional travel – 10% or less.

• Regulatory Affairs Certification is preferred.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance coverage.

• Paid time off plan.

• Health savings account (HSA).

• 401k savings plan.

• Access to earned wages before payday with myFlexPay.

• Flexible spending accounts (FSAs).

• Coverage for short- and long-term disability.

• Work-Life resources.

• Paid parental leave.

• Programs promoting a healthy lifestyle.

• Eligibility for bonuses.