Director, Regulatory Affairs
The Global Regulatory Affairs team supports Avanir throughout the product development and commercial life cycle by providing appropriate knowledge/expertise/input, by communicating effectively internally and with external stakeholders and by ensuring that Avanir operates within relevant regulations.
The Director, Global Regulatory Affairs CMC, will support the life cycle management of marketed products and the advancement of the company’s drug candidates in accordance with current regulations and department procedures. Critical to this role are strong CMC regulatory strategy and leadership skills.
The incumbent will be accountable for leading the development and implementation of the global CMC regulatory strategy focusing on both investigational and marketed products, working to ensure timely delivery of regulatory milestones and approvals for Avanir’s programs. This individual will work closely with the product development and supply management team and the Quality Assurance group, as well as other key company partner teams to ensure successful technology transfer and manufacture buildup.
This role will support all CMC regulatory affairs activities for the Avanir’s products and research, provide CMC regulatory input for global regulatory submissions to Global Regulatory Authorities (i.e., FDA, EMA, etc.), and manage the compilation and review of CMC sections of all submissions for completeness. Key to the success of the role will be the ability to foster and enable close collaboration with the regulatory function and all other key functions – team collaboration and cross functional influencing skills are a must.
Essential Job Functions:
- Serve as a subject matter expert on CMC regulatory related issues by communicating proactively and effectively with the VP Global Regulatory Affairs.
- Interface regularly with Global Regulatory Leads (GRLs) to maintain an overview of upcoming submissions for all products and, when necessary, establish prioritization between the different products under the direction of the VP Global Regulatory Affairs
- Provide CMC regulatory support, guidance and expertise to internal and external groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines
- Provide CMC regulatory affairs leadership, oversight and strategy in support of product assignments, including but not limited to CMC regulatory strategies, regulatory requirements in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.
- Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
- May liaise and negotiate with global regulatory authorities for CMC development in order to expedite regulatory approvals, including resolution of key CMC regulatory issues.
- Analyzes trends and evaluates the impact of changes in Regulatory requirements for CMC related submissions; communicates changes to appropriate areas to ensure compliance with required standards.
- Oversees the preparation of CMC packages to support global investigational and marketing registration applications and ensures timelines are met.
- Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
- Builds partnerships with key stakeholders from other functions and corporate partners to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of regulatory guidance and insights.
- Actively monitors current and emerging regulatory and scientific issues and assesses impact on company’s development programs.
- Proactively influences the development of internal and external regulatory policies, guidance, and standards.
- Supports project team goals and organizational initiatives
- Accountable for the overall planning and management of Regulatory CMC resources and budget.
- Maintains a performance and improvement culture.
- Travel (domestic and international).
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
- Bachelor’s Degree required or its equivalent in a regulatory affairs related field.
- 15+ years of experience in the pharmaceutical/biotechnology industry, 10 of which are in CMC Regulatory Affairs.
- 8+ years Leadership/management of Regulatory CMC activities and demonstrated organizational/planning skills.
- Strong technical skills, as well as demonstrated understanding of pharmaceutical operations (e. g., manufacturing, process development, analytical, quality assurance).
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data.
- Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs
- Highly knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).
- Strong proven hands-on CMC Regulatory Affairs experience and knowledge of CMC regulatory submission requirements for global filings (FDA and/or EMA, etc.) is required.
- Strong understanding of pharmaceutical development, the regulatory environment, project management, and medical terminology.
- Strong knowledge of US and other major global (ICH, EU, Asian) regulatory requirements.
- Skilled in conflict resolution/negotiation, and ability to influence the decisions of others using facts, logic and credible personal presence, and to act in the interest of the business to reach agreement with internal/external groups
- Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD viewing tools.
- Ability to build and manage relationships with business partners.
- Ability to multi-task in a very fast-paced environment, pay close attention to detail, and follow projects through to completion to meet deadlines.
- Ability to work independently as well as work in a team environment with changing timelines and priorities.
- Ability to manage changing departmental priorities, evaluate and assign resources, and communicate timeline and resource impacts to project teams and management is required.
- Must be able to effectively collaborate with peers and comfortable working in a matrixed team.
- Must be solutions oriented and pragmatic (with analytical thinking and problem-solving skills).
- Excellent project management and organization skills is a must.
- Excellent communication skills (verbal and written) and interpersonal skills.
As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.
Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com
Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en
Avanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries
Learn more here
Job posted: 2021-02-03