Sumitomo Pharma America, Inc.

We are united in our mission to deliver patient-needed therapies sooner.

Associate Director, Regulatory Affairs

ComplianceComplianceFull TimeRemoteSeniorTeam 1,001-5,000H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

48 days ago

Salary

$156K - $195K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglish

Job Description

• Lead the planning and preparation of standalone CMC submissions and response to health authority (HA) inquiries • Define submission strategies and content; identify regulatory approval risks and propose mitigation plans • Provide authoring support as needed • Review CMC components of relevant documents and contribute to content development as appropriate • Represent Regulatory CMC in cross-functional meetings and collaborate with internal and external stakeholders on assigned projects • Partner with Quality and other functions to assess the regulatory impact of proposed changes to clinical materials and commercial products • Stay current with international and domestic regulatory requirements and best practices • Provide guidance on interpreting and implementing regulations, guidelines, company procedures, and working practices

Job Requirements

BS or MS in a scientific field (e.g. Chemistry or Biology); advanced degree preferred
8 – 12 years or 6 – 8 years (with MS degree) of relevant experience in biotech or pharmaceutical industry, with specific experience in regulatory CMC
Prior experience in lifecycle management within regulatory
Experience managing and compiling Module 3 documentation
Expertise in CMC lifecycle management for drug substance and drug product
Solid understanding of US, EU, and Canada regulations, guidelines and regulatory processes for development and lifecycle maintenance
Experience working within Veeva RIM system is preferred.

Benefits

Merit-based salary increases
Short incentive plan participation
Eligibility for 401(k) plan
Medical, dental, vision, life and disability insurances
Robust time-off policy including flexible paid time off
11 paid holidays plus additional time off for shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter