- Regulatory Submissions: Manage the Regulatory eCTD Content Planner for major filings, including investigational new drug applications (INDs), biologics license applications (BLAs), and marketing authorization applications (MAAs), tracking timelines and availability of deliverables from cross functional team to ensure accuracy, completeness, and timeliness. Escalate critical path items to relevant stakeholders as needed. Deep experience with Project Management tools such as SmartSheet, ThinkCell and/or Microsoft Project is key.
- Regulatory Compliance: Monitor and interpret relevant regulations, guidelines, and industry trends to ensure compliance with applicable regulatory requirements throughout product lifecycle. Develop internal best practices, work instructions and Standard Operating Procedures (SOP) as needed for the regulatory organization. Develop and oversee timelines for regulatory compliance reports for assigned programs (eg. IND/BLA Annual Reports, Orphan Drug Designation Annual Reports, etc.) to ensure timely submission to regulatory authorities.
- Regulatory Intelligence: Stay abreast of changes in regulatory requirements and guidelines, assess their impact on product development and registration strategies, and communicate relevant updates to internal stakeholders.
- Quality Systems Support: Support the development and maintenance of quality systems related to regulatory affairs (e.g. Regulatory Information Management Systems (RIMS)), including document management, training, and SOP development, to ensure compliance with regulatory requirements. Experience with Veeva RIMS is preferred.
- Regulatory Strategy Development: Support the regulatory lead in the creation and implementation of regulatory strategies for product development and registration in alignment with business objectives and regulatory requirements.
- Regulatory Agency Interactions: Support the regulatory lead in preparing for Health Authority meetings with agencies, including the FDA, EMA, and other global regulatory authorities, representing the company in regulatory interactions, meetings, and submissions. Develop and oversee timelines for authoring of meeting materials (meeting request, briefing document, etc.), to ensure timely execution of high-quality documents by cross functional team.
- Cross-Functional Collaboration: Collaborate with cross-functional teams, including Clinical Development, Nonclinical Development, Quality Assurance, Analytical Development, Manufacturing, and Legal, to provide regulatory guidance and support for product development, manufacturing, and commercialization activities.
- Risk Management: Identify regulatory risks and develop mitigation strategies to proactively address potential issues that may impact product development or regulatory approval.
- Bachelor's degree (BS) required. Life science and advanced degree preferred.
- Minimum of 7+ years' experience in drug development and a minimum 4+ years in regulatory affairs.
- Prior BLA, sBLA, NDA, sNDA, or MAA experience is preferred.
- Prior IND, CTA and IMPD experience is required.
- Experience with the regulation of biologics is essential; experience with gene editing and/or cell and gene therapy is preferred.
- Proficiency in Microsoft Office, regulatory information management systems (RIMS), and project management tools such as SmartSheet, ThinkCell and/or Microsoft Project is mandatory.
- Strategic, analytical, and process-oriented, with superior attention to detail.
- Strong planning, organizational, and execution skills.
- Capable of developing and applying innovative solutions to resolve potential issues and meet deadlines.
- Ability to work collaboratively within a cross-functional/global team setting, and with colleagues with different backgrounds and experience levels.
- Excellent verbal and written communication skills.
- Capable of fostering open discussions and driving alignment.
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Senior Manager, Regulatory Affairs - Cambridge, United States - Editas Medicine
Description
At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we're committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary
As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy for our programs in clinical development. You will collaborate closely with the global regulatory lead and cross-functional teams to navigate complex regulatory requirements and facilitate the successful development, registration, and commercialization of our products.
Key Responsibilities:
As the Senior Manager, Regulatory Affairs, you will be responsible for:
The ideal candidate will possess:
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
