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Manager Regulatory Affairs
Join Premier Consulting and be a part of a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
We’re seeking a Manager, Regulatory Affairs who is passionate about driving innovation from the earliest stages of development. As a member of the Premier Consulting team, you’ll build cross-functional partnerships that enable your growth and success. Help us create tangible solutions for patients in need.
Your Core Responsibilities:
In this role, you will provide regulatory support for clinical trial applications, which includes investigational new drug applications and clinical trial applications, marketing applications, and ongoing trials and post approval activities. In addition, you will be responsible for working with cross-functional teams to manage the preparation, review and assembly of regulatory submissions to U.S. and international health agencies. You will contribute to regulatory strategy, identify risks and opportunities, and lead both simple and complex regulatory applications and manage procedures through approval. You will align client objectives with clearly defined scope of work and deliverables, may manage internal project resources, deliver projects/programs on time & on budget, and ensure overall client satisfaction. Additionally, you will support the client project team that authors and reviews all materials required in submissions and interact with regulatory agencies. You also may supervise or manage others within the Regulatory Affairs skill group.
Roles and Responsibilities:
- Prepare submissions and oversee the maintenance of regulatory filings to support multinational trials (i.e., INDs, CTAs, amendments, safety updates, and Annual Reports)
- Review clinical trial documents including clinical protocols/reports, investigator brochures and, nonclinical reports
- Assist in the preparation and review of regulatory filings to support U.S. and international marketing applications, applications under review by health agencies, and post-approval products (i.e., NDAs, supplements, MAAs, variations, Annual Reports)
- Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input
- With some supervision, liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests
- Lead the preparation of submissions, which may include INDs, CTAs, and briefing documents
- With some supervision lead global regulatory activities for PIP/pediatric plans, Orphan Drug applications, Break Through designations
- Coordinate with cross-functional teams to define contributions to submissions
- Interface with international affiliates on regional regulatory strategy and implementation plans
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
- Contribute to the development and maintenance the Regulatory Affairs working practices and procedures
- Conduct business development efforts, if assigned
- Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs skill group
- May be responsible to review and approve timesheets and expense reports and to guide the performance of assigned staff
Why choose Premier Consulting, a division of Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Learn more here
Job posted: 2022-04-24