Regulatory Strategy Lead for US & Canada

Azurity Pharmaceuticals - US; Woburn (MA); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Hybrid work model

401(k) matching

Tuition reimbursement

Paid time off

Job summary

Azurity Pharmaceuticals in the United States is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and to lead Health Authority submissions in the US and Canada.

This role will represent Regulatory Affairs on cross‑functional teams, drive regulatory strategy for drug registrations and lifecycle management across North America, manage IND/NDA/ANDA/DMF filings, and provide guidance to senior leadership.

Qualifications

• Minimum Bachelor of Science or preferred advanced health care discipline degree or equivalent qualification.
• 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.
• Track record of successfully working with cross-functional teams, including external partners
• Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
• Keen attention to detail.
• Ability to rapidly adapt to changing environment and circumstances that require flexibility, tolerance and urgency while ensuring regulatory requirements are met.
• Ability to communicate, negotiate and influence regulatory strategy to key stakeholders.

Responsibilities

• Represent Regulatory Affairs on product and project 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.
• Drive regulatory strategies for drug product registration and lifecycle management across North America.
• Manage regulatory filings including IND, NDA, ANDA, NDS, DMF for various dosage forms.
• Respond to FDA or Health Canada Requests for Information.
• Manage archive and timelines for regulatory submissions.
• Provide regulatory guidance on post-approval changes for assigned products.
• Support SLT and ELT meetings and presentations.
• Monitor evolving regulations and provide strategic guidance to cross-functional teams.
• Assist in preparing budgets and reviewing invoices for filings and fees.
• Participate in setting goals and process improvements within the regulatory department.

Skills

Regulatory affairs

FDA liaison

Health Canada liaison

Cross-functional teams

Project management

Excellent communication

Education

Bachelor's degree in life sciences

PharmD/PhD/MS preferred

Tools

MS Office

Job description

Azurity Pharmaceuticals in the United States is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and to lead Health Authority submissions in the US and Canada.

This role will represent Regulatory Affairs on cross‑functional teams, drive regulatory strategy for drug registrations and lifecycle management across North America, manage IND/NDA/ANDA/DMF filings, and provide guidance to senior leadership.