Sr. Manager of Regulatory Affairs

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

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.

• Provide responses to regulatory agencies regarding product information or issues;
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence;
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards;
• Develop regulatory strategies and implementation plans for the preparation and submission of new products;
• Maintain current knowledge of relevant regulations, including proposed and final rules;
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes; and
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

Requirements:

Bachelor’s degree or foreign equivalent in regulatory affairs, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine or a related life sciences field, plus three years of experience in the job offered or in regulatory affairs in the pharmaceutical industry working with 505b2 and 505j FDA applications.

Travel:           The position requires travel to client sites or Azurity Pharmaceutical’s other offices nationwide once per year for two to three days.  

Hours:            40/week, 9:00 a.m. – 5:00 p.m.

 Location:        Remote work nationwide with the option to work at one of the company’s offices noted below (Raleigh, Woburn and Atlanta) on a hybrid schedule (3 days in the office and 2 days remote)

                       

• 8 Cabot Road, Suite 2000, Woburn, MA 01801
• Six Concourse Parkway, Suite 1800, Atlanta, GA 30328
• 900 Ridgefield Drive, 2nd Floor, Raleigh, NC 27609

Apply by resumes marked to:

Lisa Sheehan

Azurity Pharmaceuticals, Inc.

8 Cabot Rd., Suite 2000

Woburn, MA 01801

Lisa.sheehan@azurity.com

Applicants should report to the employer, not to the local Employment Service Office.  This notice is being provided as a result of the filing of an application for permanent alien labor certification for the relevant job opportunity.  Any person may provide the documentary evidence bearing on the application to the Certifying Office of the Department of Labor located at the following address:

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required

Benefits We Offer:

• Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.