Regulatory Affairs Manager

463

Workplace Type: Remote

The Regulatory Affairs Manager (RA) is responsible for partnering cross-functionally with team members/leaders to develop and implement global regulatory strategies to drive pipeline development and lifecycle management activities for contracted clinical programs to ensure successful initiation, execution, submission and approvals for international registrations. Managing all aspects of Regulatory Affairs deliverables, including but not limited to ensuring regulatory compliance and meeting clinical trial and regulatory performance deliverables.. Contributing to the development and growth of the regulatory affairs service provision through collaboration across departments with the establishment and maintenance of client relationships. The RA Manager will be a strategic business partner, providing strategic input into business development proposals, and developing departmental policies, procedures, and processes. 

Responsibilities: 

• Serving as the regulatory primary point of contact for assigned projects and with regulatory agencies.
• Plan, direct, and/or coordinate regulatory activities to ensure compliance with regulations and standard operating procedures.
• Utilize strategic regulatory thinking along with technical expertise to develop, review, maintain and implement new product development/new product introduction/lifecycle management regulatory strategies and plans to ensure continued access to products globally. In line with client objectives, working cross functionally & closely with the project team.
• Preparation, submission and maintenance for products in development, new or existing products to regulatory authorities with international Regulatory Affairs affiliates; for contracted programs to meet or exceed  submission deadlines.
• Managing regulatory agency submissions (eCTD, IND applications, Clinical Trial, NDAs, BLAs, MAA’s, Amendments, Variations, Renewals).
• Monitor emerging trends within the global regulatory environment to determine potential impacts on organizational processes.
  • Regulatory representative in a working group as required to partner with cross-functional representatives to conduct detailed gap analysis and to communicate assessments of the business impact of new and changing regulations to internal and external stakeholders with senior oversight and support as required.
• Manage and implement process and technical regulatory improvements for the Global Regulatory Affairs organization.
• Review and provide feedback on SOPs, including, but not limited to internal company procedures related to regulatory, clinical, & pharmacovigilance activities, regulatory support during audits/inspections, and educational materials.
• Educate colleagues on regulatory policies and practices.
• Provide guidance to business leadership to optimize strategies across functional areas.
• Exercise highly complex level of independent judgment and execution directly impacting the operational results of the organization; manages, oversees and balances resource allocation across critical projects.
• Establish and ensure deployment of learning initiatives and training for cross-functional partners on current and emerging regulatory and related requirements.
• Ensure that company policies, procedures, and practices comply with appropriate regulatory requirements.

Qualifications:

• Minimum requirement of a Bachelor of Science degree in Life sciences, Chemistry, Pharmacy, or equivalent comparable work experience.
• MS/MSc., PhD or other advanced degree is preferred but not essential.
• Minimum 5+ years relevant regulated industry (MedTech/Pharma/CRO) experience required.
• Significant experience in all aspects of meeting and communicating with Regulatory/Health Authorities supporting drug development. Prior interactions with the FDA and/or Health Canada, acting as the agent/scientific officer respectively with robust understanding of the eCTD format, highly desired.
• Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables.
• Expert knowledge of the applicable regulatory framework as applied to different healthcare sectors such as for Drugs and Medical Devices.
• Previous experience with drug/biologic or combination product regulations strongly preferred .
• Global clinical trial experience required.
• Product licensing (NDA/BLA/MAA) and post marketing experience is desirable.
• Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint; Regulatory Information Management Systems.
• Leadership skills with ability to motivate, mentor and develop junior staff, including excellent verbal, written communication, and presentation skills.
• Tailors communication (e.g. content, style, and medium) to diverse audiences. Communicates equally effectively at varied organizational levels. High level of written, presentation, and verbal communication skills. Excellent interpersonal and organizational skills with attention to detail.
• Understanding of study financial management, regulatory resource allocation and utilization.
• Organizes and executes multiple projects/ tasks. Organizes work flow processes to achieve efficiency. Adapts to situational variables and unexpected changes in circumstances.
• Ability to work independently in a fast-paced environment with minimal oversight and a sense of urgency if the situation dictates it.
• Thorough understanding of the skills and knowledge relevant to the function coupled with strong business acumen. Successful experience in a variety of complex assignments under normal supervision.
• Contribute to the development, enhancement and expansion of regulatory services to support client development and growth.
• Understands the needs of others. Adapts style to work effectively with partners, building consensus, trust and respect. Enjoys a genuine collaborative relationship with customers.
• Ensures standardization is applied to all processes- creating, developing, improving, and complying with standards. Proactively identifies process improvement opportunities while taking industry trends and best practices into consideration.
• Searches for ways, ideas and mechanisms to add value to the customer. Develops services and options to support ongoing customer relationships. Prioritizes customer issues and addresses them accordingly.
• An analytical and problem-solving mindset. Establishes adequate data gathering and analyses policies and procedures. Challenges assumptions and their underlying logic as well as seeks input from multiple sources to gain a clear and comprehensive understanding of an issue.
• Ability to effectively interact internally and externally, with regulatory authorities/bodies, clients, project team(s), senior leadership.
• Contributes to change initiatives with enthusiasm and is a supporter of ideas and innovation. Serves as a resource for problems affecting moderate scale projects or systems. Serves as a resource to others.
• Business proficient in spoken and written English language.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.