Senior Program Director, Commercial Regulatory Affairs

Software Guidance & Assistance, Inc., (SGA), is searching for a Senior Program Director, Commercial Regulatory Affairs for a contract assignment with one of our premier Pharmaceutical clients in South San Francisco, CA .

Responsibilities :
Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry.

The CORA Department reports into the Head of U.S. Regulatory Affairs and is focused on the U.S. Market. Program Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for the firm's pharmaceutical products. Senior Program Directors may be assigned responsibilities for leading complex product launches, combination product PRCs, departmental programs, projects or other deliverables with limited direction. Like Program Directors, Senior Program Directors will coordinate assigned deliverables and guide these when working with other team members, including within and outside of CORA.

• Senior Program Director (E5A) is the specialist individual contributor position for CORA Review.
  • Lead Program Review Committees (PRCs) independently
  • Assume responsibility for leading significantly complex product launches, combination product PRCs, departmental programs, projects and other deliverables with limited direction
  • Demonstrate mastery of the review committee process and regulatory technical knowledge
  • Are the decision-makers for the PRCs in their designated therapeutic or business area assignments; independently leading cross-functional PRCs and modeling strong facilitation and decision-making skills
  • Support development of therapeutic-area strategy, conducting and summarizing product-specific analyses
  • Represent the firm in official FDA communications and sign-off on 2253s
  • May serve as a subject matter expert (SME) for CORA with other departments
  • Can effectively lead complex department projects (organizational design, long-range budget, capacity planning, organizational effectiveness, employee engagement, CORA strategy, vision, strategic objectives, etc.)
  • Require limited direction to complete standard and non-standard work
  • Are relied upon for sound regulatory guidance and apply a strategic approach to problem-solving
  • Effectively integrate regulatory, legal and commercial context and business knowledge to address significantly complex problems
  • Keep current in the areas of regulatory, healthcare compliance and ethics
  • Proactively identify and address compliance issues
  • Regularly lead cross-functional interactions, projects and teams
  • Represent CORA on cross-functional review/decision-making committees of significant impact across the organization
  • Typically operate with a planning horizon of 12 -18 months
• PRC Leadership:
  • Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area. Typically assigned PRC responsibilities for complex products or business areas
  • Serve as Functional Leader for CORA with internal partner groups, developing plans to strengthen PRC and other key regulatory review processes
  • Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc.
  • Represent the firm in official FDA communications and sign-off on 2253s
  • Act as a primary firm liaison to the FDA on relevant CORA activities
  • Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for the firm's products
  • Obtain and apply in-depth knowledge of the firm and regulatory guidelines, policies, procedures and best practices
  • Maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders
  • Collaborate with commercial leadership to influence marketing strategies, implementation and promotion objectives
  • Facilitate the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and the firm's policies
  • Provide regulatory input on concepts and draft materials
  • Develop and implement effective strategies for FDA marketing, advertising and communications submissions
  • Develop and deliver initial correspondence with the FDA and manage interpretation of FDA comments.
  • Oversee and guide follow-on correspondence, such as resubmissions
  • Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development
  • Support development of the cross-functional regulatory strategy for each product or portfolio assignment by providing commercial regulatory affairs expertise, insights, perspective and recommendations
  • Provide oversight and decision-making leadership to junior CORA staff as well as day-to-day guidance to other CORA team members supporting the same PRCs or other assignments
  • Keep internal partners and stakeholders abreast on primary PRC/CORA activities and status
  • Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations
• Other:
  • As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products
  • As appropriate, represent CORA cross-functionally and support effective and efficient cross-functional coordination, appropriate resources, and timely, thorough and compliant execution
  • Coach and mentor new or less experienced CORA staff members. Be viewed and respected as a leader within CORA
  • Lead other special projects, as and when assigned, or otherwise requested

Required Skills :

• Bachelors Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred)
• Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline)
• 7 or more years' work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry
• 4 or more years' previous experience leading large-scale, cross-functional project teams or other forums in design, development and implementation of policies, programs or projects with significant organizational impact strongly preferred
• Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.)
• Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, firm Values, Competencies and Leadership Commitments (where applicable)
• Regarded as a subject matter expert in regulatory
• Consistently provides expertise and support in guiding cross-functional projects/teams to mitigate risks and capitalize on opportunities
• Strong influencing and negotiation skills: proven effectiveness leading diverse teams and influencing stakeholders of varying organizational levels without direct authority
• Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications
• Prepares well-researched and properly-toned emails in response to policy questions
• Thinks "outside the box" for solutions. Applies creative problem-solving and appropriate business solutions to effectively address compliance risk
• Excellent project management skills; can prioritize multiple tasks and goals to ensure timely, on-target and within budget accomplishment of such
• Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources
• Strong business acumen: understands how the business "works" and demonstrates consistently effective "navigation" across the organization
• Strong process orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness
• Ability to travel (?10%)
• Strategic Agility - Articulates wise, long-term objectives and strategies. Provides focus and direction to successfully navigate complexity and uncertainty. Links responsibilities with the mission of the whole organization. Regularly updates plans to reflect changing circumstances. Focuses on activities that provide the most value.
• Decision Making - Understands the broad context for decisions and reflects that context in how decisions are made. Makes good decisions even in the face of ambiguous circumstances or contradictory requirements. Able to manage divergent perspectives and to deliver difficult or unwelcome information in a constructive and productive manner. Expresses regulatory position and rationale, fluently and eloquently. Encourages direct and open discussions about important issues - and is able to eliminate churn and drive toward clarity.
• Inspiring and Influencing - Infuses the organization with a sense of purpose. Is able to pull people together to achieve a common goal. Addresses and resolves conflict by creating an atmosphere of openness and trust. Establishes strong collaborative relationships. Inspires others to do their best work by offering support and encouragement. Rallies support throughout the organization to get things done. Fosters an exchange of ideas and support amongst colleagues. Is good at promoting an idea or vision: persuading. Works effectively with other people over whom has no direct authority.
• Understands what motivates other people to perform at their best.
• Technical and Business Expertise - Demonstrates ongoing commitment to reduce complexity across the organization. Builds alliances with internal and external customers that strengthen our reputation and create new value. Has a firm grasp of internal and external conditions affecting the organization. Applies emerging knowledge and trends in one's area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond their area.
• Managing Change - Effectively manages change; explaining the context, answering questions, and patiently listening to concerns. Effectively involves key people in the design and implementation of change. Introduces needed change even in the face of opposition.
• Innovation - Consistently generates new ideas. Leverages the unique talents and viewpoints of others. Seeks new opportunities and tries new approaches.

Preferred Skills :

• Regulatory advertising and promotion experience strongly preferred

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
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