Director/Sr Director, Global Regulatory Strategy Lead

Location
San Diego, California
Posted
Oct 23, 2017
Ref
2017-1031
Required Education
Bachelors Degree
Position Type
Full time

The Opportunity
The Global Regulatory Strategy Lead (GRSL) will have leadership responsibility for global regulatory strategy within a Product Development Team (PDT).  Additionally, the GRSL serves as a team lead or co-leads of marketing application submission teams for indications that are in late-stage development. Key responsibilities include but are not limited to:

• Leads the development of strategy and content for global dossiers
• Develops target labeling and co-lead the cross-functional labeling team.  Ensure consistent positions are presented in responses to global health authority (HA) queries
• Ensures global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input
• In collaboration with the EU regulatory lead, develops global submission plans and HA interaction plans
• Provides input into the development of protocol synopses and protocols
• Co-leads the cross-functional response teams to respond to IND and Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with Health Authority (HA) deadlines

What You’ll Dive Into
• Leads the development of regulatory pathways and plans for product registration, including associated risk assessments and identification of precedence
• Participates in the development of strategies for product partnering (out-licensing, divestiture, co-development, in-licensing, and acquisitions)
• Drives the creation and execution of the global submission plan; Formulates integrated global submission plan(s) for simultaneous filings and communicates rationale for deviation from simultaneous submissions
• Leads the content planning for regulatory submissions, strategic documentation and project reviews; Aligns regulatory plans with commercial and development plans
• Assures that priority market and non-priority market regulatory issues are addressed in the global development plan
• Assures CMC elements of the overall global regulatory plan are robust
• Provides strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, and DMC charters, etc.; Reviews and approves key regulatory documents, including IBs, INDs, IMPDs, CTAs, RMPs, and Pediatric Plans
• Facilitates identification and internal agreement of optimal product labeling; Provides strategic input on Target Product Profile, CCDS and country-specific labels
• Supports effective interactions with HAs globally; Creates an asset-specific global HA interaction strategy, integrating regional/local objectives and strategies; Supports the preparation of, and participates in/leads (as appropriate), key HA interactions, ensuring consistent positions on common issues are presented to global HAs; Reviews and approves content of responses to queries from HAs for respective regions/countries
• Establishes one regulatory voice for communication to key stakeholders

What We Expect
• MD/PhD, PharmD, MS or BS with equivalent professional experience based on education
• 12+ years of industry experience w/a minimum of 8+ years in progressive regulatory roles
• Significant experience and expertise in developing regulatory strategies across the clinical, marketing, product development and commercialization process
• Significant experience w/US FDA regulations; Strong understanding of global Health Authority (HA) policies, laws, regulations and guidelines as they apply to global drug development and approvals (e.g, EMA; EU)
• Significant knowledge of medical and scientific content and associated complexities
• Significant knowledge of the drug development process (early stage to commercialization)
• Experience in successfully leading submission teams
• Direct experience in developing strategy, resolving issues and interactions with Health Authority
• Demonstrated ability to coordinate global activities, drive quality decision-making, organize/prioritize tasks, negotiate with and influence others, and facilitate issue resolution and conflict management
• Effective communication skills (verbal/written/email/presentation) with friendly and collaborative interpersonal skills; Global cross-functional/collaboration experience required
• Ability to communicate regulatory strategy to key stakeholders at all levels of the organization
• Ability to travel up to 20% (US and International)

What You’ll Get
• To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
• Opportunities to learn and contribute creative solutions
• Comprehensive health insurance ($0 premium on select medical plans)
• Matching 401k retirement plan
• Paid time off and holidays including a Summer & Winter break
• Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.