Alder Biopharmaceuticals, Inc.
Vice President Regulatory Affairs
Alder is revolutionizing the way antibody therapies are identified, selected, developed and produced. Our proprietary technologies make great strides possible in the field of antibody therapeutics, yielding innovative potential new treatments for conditions such as migraine and rheumatoid arthritis.
At Alder we seek talented contributors who thrive in a high-energy team environment and want to make a real and lasting impact in the field of antibody therapeutics. Alder teams are creative, collaborative, open, committed--and central to the success of this company and its mission. If this is the kind of company you want to work for, we want to hear from you.
This position is responsible for developing corporate regulatory strategies and ensuring they are executed in compliance with current industry standards as well as local and regional requirements. Establishing the overall regulatory strategy for all regulatory submissions. Provide regulatory guidance and strategic input into all aspects of the pipeline development candidates. Establish the corporate approach to health authority communications including direct liaison with FDA and other regulatory agencies. Ensure company compliance with all applicable guidances, regulations and laws.
Specific responsibilities will include:
- Provide leadership on the development and implementation of regulatory strategy for all aspects (CMC, pre-clinical, and clinical) of corporate drug development.
- Develop and communicate regulatory strategic development plans to senior management
- Provide overall direction for the preparation and timely submission of regulatory application documents (IND/CTA, BLA/NDA) that are consistent with corporate strategy and timeliness.
- Develop, communicate and implement solution based issue resolution strategies.
- Oversee corporate liaison activities with FDA and other health authorities.
- Ensure company compliance with all applicable local and regional guidances, regulations, laws and current industry standards.
- Advise senior management of the impact the changing regulatory environment (regulations, current industry practices) can/will have on Alder business or development projects.
- Provide professional and experience based development mentoring to staff.
- Self-motivated individual who is able to manage multiple projects and priorities within a fast-paced, creative environment.
- B.S. Degree in Life Science related field required. M.S., Pharm.D. or Ph.D. preferred.
- 10+ years of experience in a leadership role in regulatory affairs along with 7+ years in a management role.
- Proven regulatory experience in all phases of drug development including recent leadership in a BLA/NDA filing.
- Experience developing therapeutic biologics and, in particular, therapeutic monoclonal antibodies is highly desired.
- International experience is a plus.
- Must have strong strategic, critical thinking, diplomacy, negotiation, managerial, and general communication skills.
Please send your cover letter and resume to email@example.com. When applying for this position, please reference job code C16-02 and let us know how you heard about this opportunity.
Alder Biopharmaceuticals, Inc.
Reference Job Code: C16-02
Alder Biopharmaceuticals, Inc. is an Equal Opportunity Employer