Senior Director, Regulatory Affairs – Global Regulatory Leader

Overview Of Role

The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as obtain and later maintain market approval for product(s) in oncology therapeutic area.

Role And Responsibilities

• Leads preparation of US, EU, Canadian and Japanese regulatory product strategies for assigned products.
• Ensures compliance with global regulatory requirements.
• Manages compounds through all phases of development, throughout the life cycle of the product
• Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers
• Advises management of the effect of current or proposed laws, regulations, guidelines, and standards, etc.
• Key internal leader and driver of regulatory policy and strategy for assigned products
• Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
• May lead the Labeling Regulatory Team
• Proactively anticipates and mitigates regulatory risks
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
• Develops and implements acceleration strategies
• Manages projects and necessary documentation of regulatory strategies
• Accountable for ensuring that corporate goals are met
• Acts independently under direction of Head of RA
• Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members
• Will have direct reports and contributes to the performance management for other RA team members
• May influences the development of regulations and guidance
• Advises internal personnel on regulatory strategies
• Designs and Implements policies and procedures for regulatory record keeping and procedures, ensures direct reports follow requirements
• Proactively informs of issues, risks and mitigations
• Provides informed regulatory opinion based on experience and expertise
• Makes decisions regarding regulatory work processes or operational plans and schedules in order to achieve the program objectives established
• May advances the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
• Follows budget allocations
• All other duties as assigned

Experience, Education And Specialized Knowledge And Skills

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject Masters or Doctorate preferred 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or ChinaRequires drug development experience in US & EU Minimum of 5+ years of proven experience in a strategic leadership role with strong project management skillsExperience working in a cross functional environment with multiple stakeholders and influencing cross-functional teams Experience interfacing with major government regulatory authorities Strong communication and proactive negotiation skills Experience developing and implementing successful global regulatory strategies Strong computer and database skills Attention to detail, accuracy, and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking, problem solving, ability to work independentlyMust be able to effectively multi-task and manage time-sensitive and highly confidential documentsCommunicate effectively and articulate complex ideas in an easily understandable way Prioritize conflicting demandsAbility to successfully work in a fast-paced, demanding and collaborative environmentTravel up to approximately 5%

Compensation

The pay range for this role is $255,000 - $275,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Referral Policy

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.