Sobi
US Regulatory Strategy Lead
Waltham, MA, United States
Sponsorship not specified$185k-$210kDetected 43 days ago
StatisticsProduct StrategyNegotiationFDA RegulatoryResearchLeadershipCommunicationProblem SolvingRegulatory Affairs
About the role
- 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.
Responsibilities
- Prepares cross-functional team for any major FDA Meetings and leads/facilitates major meetings with the Agency
- 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 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
Requirements
- Regulatory representative on due diligence assessments of new business opportunities as required
- Advanced degree (PhD, PharmD, MD) preferred but not required
- Experience with immunology late-stage development/marketed products ideal but not required.
- Must be a great team player with strong verbal and written communication skills
Compensation
- $185k-$210k
Benefits
- Generous time off policy
- Leads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDA
- 6+ years regulatory affairs experience having led health authority meetings (FDA).
Visa & Work Authorization
- Leads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDA
This listing is sourced directly from Sobi's careers page and normalized into a canonical job model.