Associate Director Regulatory

GRIFOLS, S.A.•Oceanside, CA

1d•$171,510 - $257,265•Onsite

About The Position

Develops and implements worldwide regulatory programs for marketed products and/or those for development and interactions with regulatory authorities to expedite approvals. Participate in the development of and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements.

Requirements

Knowledge and understanding of global regulations for the biotechnology and pharmaceutical industry.
Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem-solving skills.
Demonstrated project management skills.
Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
Ability to work within a global team framework and multi-cultural environment.
Bachelor's Degree in related scientific discipline.
12+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry.
Sound basis of regulatory knowledge.
Ability to write comprehensive scientific information for use in regulatory submissions.
Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation.
Ability to execute regulatory strategies through to commercialization/life cycle.
Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

Responsibilities

Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products.
Provides regulatory expertise to Research and Development to support the design and analysis of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.
Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.
Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.
Advises cross-functional teams on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
Write and review documents with complex scientific information for regulatory submissions.
and monitor project timelines and provide leadership cross functions at the level of study teams to ensure quality deliverables within defined timelines.
Monitor external vendors.