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.
- 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