Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects.  Key accountabilities include providing regulatory guidance, requirements and strategy for assigned projects, ensuring compliance with regulations, company standards and commitments.   The regulatory team works across multiple complex projects, facilitating various types of submissions to agencies like the FDA, HC, EMA, MHRA and other international authorities, by ensuring compliance with evolving regulations.

Principle Responsibilities:

• Represent Regulatory Affairs on assigned product and related project team (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 other health authorities and regulatory agencies for assigned products.
• Drive regulatory strategies for drug product registration and life-cycle management across global markets, with primary responsibility of managing submissions within North America.
• Manage regulatory filings including IND, NDA, ANDA and NDS for a variety of dosage forms including solid oral, parenteral, liquids, inhalation and nasal, and drug/device combination drug products
• 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 SOPs.
• Provide regulatory guidance on requirements for post-approval changes, as required, for assigned commercial products including change control assessments.
• Establish regulatory strategy for assigned projects with input from project teams.
• 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.

Qualifications and Education Requirements

• Minimum Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
• Minimum of 8-10 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 successfully communicate, negotiate and influence regulatory strategy to key stakeholders.
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met.
• Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.