Senior Regulatory Affairs Leader, NA Lifecycle Strategy

Azurity Pharmaceuticals - US; Raleigh (NC); Híbrido; USD 140.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

401K matching up to 5%

Vacation days and PTO

Tuition reimbursement

Annual bonus

Descripción de la vacante

Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and to serve as the regulatory voice on cross‑functional teams in North America. You will author HA submissions for US and Canada, guide strategy, and ensure compliance with regulations and Azurity standards.

You will manage filings (IND, NDA, ANDA, NDS, DMF) across multiple dosage forms, coordinate with FDA and Health Canada, monitor evolving regulations, and support SLT/ELT

Formación

• Minimum Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
• Minimum of 10 years in the pharmaceutical industry with at least 8 of those years in regulatory affairs.
• Combination of education and applicable job experience may be considered.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.

Responsabilidades

• Represent Regulatory Affairs on assigned product and related project teams (both internal and external cross‑functional teams).
• Provide regulatory assessment of due diligence requests to support new business development activities.
• Serve as primary interface with FDA and Health Canada for assigned products. Prepare and author portions of Health Authority meeting request and briefing documents. Attend Health Authority meetings as assigned.
• Drive regulatory strategies for drug product registration and for life‑cycle management across North America.
• Manage regulatory filings including IND, NDA, ANDA, NDS, DMF for a variety of dosage forms including solid oral, parenteral, liquids, topicals, inhalation and nasal, and drug/device combination drug products. Respond to FDA or Health Canada Requests for Information.
• Manage operational aspects of preparing compliant submissions to regulatory agencies.
• Establish and manage timelines associated with regulatory submissions.
• Manage archive of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms as per Azurity SOPs.
• Provide regulatory guidance on requirements for post‑approval/life‑cycle changes, as required, for assigned commercial products including change control assessments.
• Provide regulatory support for Senior Leadership Team (SLT) and Executive Leadership Team (ELT) meetings and presentations.
• Monitor evolving, region‑specific regulations and proactively provide strategic guidance to cross‑functional teams to ensure compliance.
• Assist in preparing budgets and reviewing invoices on assigned projects and relevant product/filing fees, as needed.
• Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.

Conocimientos

Regulatory affairs

FDA liaison

Health Canada

Regulatory submissions

Cross-functional collaboration

Budgeting

Educación

Bachelor of Science or advanced health care discipline (PharmD/PhD/MS) or equivalent

10+ years in pharmaceutical industry with 8+ years in regulatory affairs

Herramientas

MS Office

Descripción del empleo

Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and to serve as the regulatory voice on cross‑functional teams in North America. You will author HA submissions for US and Canada, guide strategy, and ensure compliance with regulations and Azurity standards.

You will manage filings (IND, NDA, ANDA, NDS, DMF) across multiple dosage forms, coordinate with FDA and Health Canada, monitor evolving regulations, and support SLT/ELT