Regulatory Affairs, Senior Director to VP
SUMMARY:The Head of Regulatory Affairs North America will provide strategic and tactical leadership and management of the regulatory affairs function, agency interactions and submissions for North America to achieve successful approvals of clinical trials and market authorization applications, and ensure compliance with all appropriate government regulations, industry guidelines, and best practices. In collaboration with regulatory colleagues in China, they will be responsible for devising and implementing global regulatory strategy and providing leadership oversight for regulatory submissions, regulatory compliance, regulatory advice and counseling in all areas of development, and oversight of commercial regulatory activities across the lifecycle of products for responsible territories. An integral part of this role is to foster strong relationships and advocacy with FDA as well as other international regulatory authorities. In addition, the ability to facilitate strong coordination and collaboration across internal departments and stakeholders from a global perspective is key.
DUTIES AND RESPONSIBILITIES:
- Provide leadership in the design and execution of strategies for regulatory submissions in close collaboration with other functions.
- Manage, oversee and/or prepare regulatory documents and submissions in accordance with business strategies. Direct the strategy for regulatory health authorities engagements including the request, preparation and execution of meetings and correspondences with regulatory authorities for product-specific and policy-related issues.
- Interpret regulatory requirements for company filings; oversee the processing and submission of filings.
- Represent company before regulatory authorities. Interact and collaborate with regulatory agency personnel in regard to submission and subsequent approvals.
- Collaborate with internal and external (CRO) staff to author and compile documents for submission to regulatory agencies, including INDs, CTAs, BLAs, MAAs, and NDAs.
- Ensure corporate compliance for manufacturing licenses, government reporting requirements, etc.
- Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies changes on company pipeline strategy.
- Keep management informed of regulatory status of products and significant regulatory issues.
- As the company grows, develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into future direction. Develop and mentor regulatory personnel and future regulatory staff.
- Represent regulatory with internal and external partners. Provide guidance to business development regarding critical evaluation of potential product opportunities supporting strategic partnering and licensing activities.
- Provide regulatory guidance for the planning and compilation of critical documentation related to U.S. and worldwide submissions. Proactively influence regulatory policies and implement processes to ensure company maintains market status. Be an active member of industry associations.
- An advanced degree, e.g., PharmD, PhD or MD is highly preferred. A minimum of a BA/BS within a technical related discipline is required.
- Minimum 15 years of experience in Regulatory Affairs within the pharmaceutical industry with 7 years of specific leadership and management experience.
- Experience in the leading, designing, writing, and submission of regulatory filings and correspondence within a complex specialty/branded commercial pharmaceutical organization, is required. Therapeutic area experience in infectious disease is preferred.
- Strong leadership competencies and strategic business perspectives are required to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and post-marketing activities.
Other Skills and Abilities:
- Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA. Exposure to China and EMA a plus
- In-depth understanding of the drug development, product commercialization and life cycle management processes combined with experience in Quality Assurance, Development, Clinical and Compliance is desired
- Experience and/or active involvement in co-development partnership and in/out-licensing business opportunities is a plus
- Must be able assimilate and interpret trends in the US healthcare regulatory environment that directly affect business decisions in the pharmaceutical and biotech industry
- Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups
- Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards
- Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details
- Problem Solving–Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Reasons when dealing with emotional issues.
- Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
- Communication–Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
- Leadership–Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Ethics–Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- Strategic Thinking–Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
- Judgment–Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
- Initiative–Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
- Innovation–Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Job posted: 2021-03-13