Global Regulatory Lead

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
• Summer Fridays
• 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

• Single point of contact/single point of accountability within GRA on the Core Asset Team (CTA) and Medicines Development Team (MDT) for assigned program(s)
• Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s)
• Provides global regulatory leadership of assigned program(s)
• Develops global regulatory strategies, including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients’ access
• Attends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s)
• May act as the European or US Regulatory Strategy lead (jointly with GRL role) depending on the complexity of the program and stage of development
• May present to Senior Leadership regarding assigned program(s)
• Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultants
• Participates in strategic and regulatory evaluations of in-licensing matters
• May have direct oversight of Regulatory Affairs team members supporting assigned program(s). Develops and coaches direct reports
• Authority to approve services and costs within budget and delegation from Sobi authorized signatories
• Review regulatory SOPs as needed
• Participate in operational excellence work (improvement projects) as needed

Main contacts:

• Internal core interactions: All functions within Sobi, but in particular Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, Global Medical & Scientific Affairs, Project & Portfolio Management as well as Management Teams, Governance Teams and affiliates.
• External core interactions with: Regulatory Authorities, CROs, Consultants, Partners.
• May act as point of contact with US FDA or EMA

Qualifications

• Degree in Life Sciences
• Expert on all Regulatory Affairs processes, applications and regulatory environment to achieve and maintain marketing authorizations
• Good knowledge of drug development and the rare diseases regulatory environment
• Very good knowledge in written and oral English, knowledge of other languages is an upside but not required

Personal attributes:

• Strong team-player with collaborative, respectful and flexible attitude and high engagement
• Highly self-motivated and able to drive activities, solution-oriented personality
• Excellent communication and negotiation skills
• The suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.

Location:

Europe (Basel, Stockholm) or United-States (Boston, Massachusetts)

Additional Information

The base salary pay range for this role is $175,000-$215,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

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