Associate Director/Director, Regulatory Affairs

The Associate Director/Director, Regulatory Affairs, will lead development and implementation of registration strategies as well as develop and oversee submissions and communications with Health Authorities for assigned development programs.  Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, excellent analytical and communications skills.

Responsibilities

  • Responsible for developing global regulatory strategies for assigned programs.
  • Regulatory document generation, as needed, as well as review and approve relevant documents 
  • Oversee strategy, preparation, and submission of regulatory submissions.
  • Represents regulatory affairs on cross-functional project teams to provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
  • Develops and manages regulatory submissions and related supplements and amendments, works closely with consultants and contractors to coordinate publishing, and other submission activities.
  • Interacts directly with health authorities and maintains excellent relationship with regulatory personnel.
  • Educates company on regulatory requirements and evolving trends and disseminates regulatory intelligence relevant to the business.
  • Interact routinely and develop strong collaborative relationships across the company and externally with vendors, CROs, as appropriate.

Qualifications and Experience

  • 8+ years of regulatory affairs experience in the biopharmaceutical industry.
  • Demonstrated competency in drug development process and understanding of scientific content and complexities. Experience in anti-infectives therapeutic area is a plus.
  • Strong understanding of global and US policy, laws, regulatory and guidance/ guidelines.
  • Familiarity with regulatory requirements outside the United States, eg, EU.
  • Strong communication and presentation skills to ensure the regulatory strategy is clearly articulated in cross-functional teams. 
  • Strong writing skills with experience in drafting and submitting timely drug submissions to health authorities.
  • Track record of building an excellent relationship with the FDA and other regulatory agencies.
  • Strategic thinker with excellent problem solving and influencing skills.
  • Familiarity with special status such as QIDP, orphan, fast track, and breakthrough designations.
  • RAPS Certification is a plus.

Spero has a vibrant and engaging culture of innovation and team work and we are continuing to build a top-tier team to rapidly advance our programs in a fast-paced, exciting and fun work environment. We offer a robust benefits package including premium health/dental plans, 401(k) retirement plan, incentive stock options, 4 weeks paid time off, professional development, and frequent social opportunities.

Please forward your CV/resume to Careers@sperotherapeutics.com

Spero Therapeutics, Inc. 675 Massachusetts Avenue, 14th Floor, Cambridge, MA 02139

www.sperotherapeutics.com