US Regulatory Strategy Lead at Sobi

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

245000.0

Posted On

13 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Global Regulatory Team, US Regulatory Framework, Risk Assessments, Mitigation Strategies, Expedited Regulatory Pathways, FDA Meetings, Health Authority Communications, Submission Taskforce, Regulatory Consultants, Product Labeling, IND Submissions, NDA Submissions, BLA Submissions, Due Diligence, Leadership

Industry

Pharmaceutical Manufacturing

Description

Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: Competitive compensation for your work Generous time off policy Opportunity to broaden your horizons by attending popular conferences Emphasis on work/life balance Collaborative and team-oriented environment Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments Job Description The US Regulatory Strategy Lead is responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products. He/she is a critical member of the Global Regulatory Team (GRT) providing US-focused product strategy, US regulatory framework knowledge, and awareness of external regulatory initiatives. The US Regulatory Strategy lead partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams including MDT and CAT, representing Regulatory on an agenda driven basis. The US Regulatory Strategy Lead will present the US regulatory position on assigned products to Sobi Stakeholders, as needed. The USRL develops US regulatory strategies, including risk assessments, mitigation strategies, and champions use of expedited regulatory pathways for accelerated patients’ access in the US Key responsibilities, including, but not limited to the following: Core member of the GRT collaboratively working with the team to weave US strategies into global strategies as they are developed US participant on Sobi Product Cross Functional Teams as appropriate Point of contact within GRA on the core asset team (CAT) and Medicines Development Team (MDT) for assigned program(s) Ensures guidance on regulatory pathways to accelerate product development (e.g. ODD, FTD, Accelerated Approval, Priority Review, etc.) is evaluated and included where possible in the US Strategy Prepares cross-functional team for any major FDA Meetings and leads/facilitates major meetings with the Agency Leads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDA Contributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions of major application(s) is executed successfully Point of contact and lead with regulatory consultants and facilitates meetings and any communications shared between regulatory and its consultants Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners, and regulatory consultants Key contact for FDA on product(s) and with direct FDA interaction. Ensures communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps Key contact for development and business partners on product(s) Contributes to US product labeling, working with the GRL and Labeling group to ensure core label changes are appropriately conveyed in US product labeling; Partners with US Commercial and Ad Promo Team Responsible for IND, NDA, and BLA submissions to FDA in partnership with Regulatory Operations Regulatory representative on due diligence assessments of new business opportunities as required Reviews regulatory SOPs as needed Participates in operational excellence work (improvement projects) as needed May represent Sobi on industry work events and attend public meetings Monitors and assesses impact of relevant US regulations, guidance and current regulatory environment Qualifications Education/Learning Experience/Work Experience BS in a scientific discipline. Advanced degree (PhD, PharmD, MD) preferred but not required 6+ years regulatory affairs experience having led health authority meetings (FDA). Ideal candidate will have delivered at least one major application (NDA/BLA or sNDA/sBLA) Experience with immunology late-stage development/marketed products ideal but not required. Other therapeutic areas will be considered Great leadership skills with high emotional intelligence Must be a great team player with strong verbal and written communication skills Skills/Knowledge/Languages Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards Proven track record practicing sound judgment as it relates to risk assessment Highly conversant and knowledgeable of new and emerging regulations and guidance. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information Fluent written and verbal communication, presentation, and facilitation skills in English Personal Attributes High ethical standards and ability to demonstrate Sobi values Strong negotiation skills and significant experience in interacting with regulatory authorities Risk identification and problem-solving skills Actively demonstrates cross cultural sensitivity and inclusive behavior Ability to manage complex issues and coordinate multiple projects simultaneously Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. The base salary range for this role is 210,000 – 245,000 USD. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable assets, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases ,and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected] Know Your Rights Sobi Location: United States

Responsibilities

The US Regulatory Strategy Lead is responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products, serving as a critical member of the Global Regulatory Team providing US-focused product strategy. Key duties include developing US regulatory strategies, leading major FDA meetings, managing FDA communications, and contributing to IND, NDA, and BLA submissions.