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Manager/Sr. Manager Regulatory Affairs at Immune Design
South San Francisco, CA, US
Overview

The Manager/Sr. Manager, Regulatory Affairs implements and ensures RA deliverables associated with projects and assignments are completed within defined timelines and meet regulatory and other company guidelines.
Responsibilities

Responsible to ensure all RA deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and company guidelines
Oversees, coordinates and delivers on regulatory submissions and other relevant regulatory documentation
Leads process for filing IND/NDA/CTA submissions.
Participate in the strategic identification of existing pathways for regulatory approvals.
Build relationships and trust with key internal and external stakeholders.
Identify and Insure RA issues are highlighted and addressed satisfactorily and in a timely fashion.
Review and file regulatory documents (protocols, IB’s, Annual Reports, etc.)
Provides regulatory expertise and leadership to cross-functional teams and other groups
Serves as the primary RA representative on two or more projects at any one point in time
Analyzes data, the regulatory environment and business objectives to recommend priorities
Provides internal teams with direction on regulatory authority interactions
Develops regulatory risk management and contingency plans. Communicates plans to management, as appropriate
Participates as a standing member in various teams, dependent upon assigned projects and the associated programs, coordinates cross-functional contributions and collaborates in shaping the product’s strategy.
Qualifications

Bachelors Degree required (life sciences disciplines strongly preferred)
Average of 5 or more years’ relevant experience in regulatory affairs or related functions in biologics clinical development
Broad understanding of international regulations, processes and issues in drug/biologics development.
Experience as a regulatory lead/co-lead for global original IND/NDA/MAA filings in the US or Europe
Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
Outstanding attention-to-detail
Sound knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
Outstanding written communication skills
Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
Works well within teams and is effective in collaborating with others internally and externally