Senior Manager, Regulatory Affairs

Regulatory Toolkit; Woburn (MA); Ibrido; USD 140.000 - 190.000; Tempo pieno

Descrizione del lavoro

Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and serve as the regulatory representative on cross-functional teams. Responsibilities include authoring HA submissions for US and Canada and ensuring compliance with evolving regulations across North America.

The role requires directing regulatory strategies for drug product registration and lifecycle management, managing submissions (IND/NDA/ANDA) across multiple dosage forms,

Competenze

• Minimum Bachelor of Science or advanced health care discipline degree or equivalent.
• Minimum of 10 years in the pharmaceutical industry with at least 8 years in regulatory affairs.
• Experience working with cross-functional teams and external partners.
• Strong written and verbal communication skills; proficient in MS Office.

Mansioni

• Represent Regulatory Affairs on cross-functional teams for assigned products/projects.
• Provide regulatory guidance and determine requirements/strategy for submissions.
• Prepare Health Authority submissions for US and Canada and manage regulatory filings (IND, NDA, ANDA, NDS, DMF).
• Monitor regulatory changes and advise teams to ensure compliance.

Conoscenze

Regulatory affairs

Project management

FDA liaison

Cross-functional collaboration

Regulatory strategy

Formazione

Advanced health care degree (PharmD/PhD/MS)

Strumenti

MS Office

Descrizione del lavoro

At Azurity, we're redefining medicine for the real world. Most medicines are designed for how they're approved; ours are built for real life. That shift drives everything we do. We challenge the status quo — repurposing proven molecules with intention, reimagininghow therapies are designed, delivered, and accessed so they work in the realities of everyday life. And with a diversified and growing portfolio, we bring the agility, scale, and global reach to deliver meaningful solutions to patients, providers, and healthcare systems around the world. Because medicine should fit into life, not force life to fit around it. With more than 70 medicines across 11 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com and LinkedIn.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

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. Project may support developmental product activities as well as the life-cycle management of commercial products. Responsibilities include providing regulatory guidance, determining requirements and strategy for assigned projects, authoring Health Authority (HA) submissions for US and for Canada, and ensuring compliance with regulations, company standards and commitments.

Principle Responsibilities:

• 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.

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 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 a great sense of urgency while ensuring that all regulatory requirements are met.
• Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

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