The Associate Director, Regulatory Affairs develops regulatory objectives, advice, and strategy in alignment with corporate goals. Plans and manages regulatory document preparation for regulatory submissions to global health agencies. Keeps abreast of evolving regulatory procedures and practices.
- Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings.
- As a member of study teams, provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
- Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.
- Contribute to identification of issues, gaps and trade offs affecting submission and approval.
- Support and manage preparation of meeting requests and briefing documents.
- Author/edit documents to support regulatory submissions.
- Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Support the organization and record regulatory meetings with health authorities.
- Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
- Manage contract staff and vendors as needed to support regulatory activities.
- Provide create and innovative solutions while being an advocate for compliance.
- Train and mentor regulatory staff.
- Assist with SOP generation and contribute to improvements in department best practices.
- Perform other duties as required, interfacing with other departments, CROs and external vendors as needed.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- 7+ years of experience in Regulatory Affairs strategy for pharmaceutical, biotech, or medical device products in the US market.
- Global regulatory experience a plus.
- Regulatory Strategy experience with both development and commercial products.
- Bachelor of Science in a scientific discipline.
- Strong knowledge of eCTD elements and structure.
- Strong regulatory writing skills and use of Microsoft Word.
- Experience working with all levels of management and consulting with key business stakeholders.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication.
All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.