Associate Director, Regulatory Affairs

Bothell, WA

Purpose

The Associate Director, Regulatory Affairs will support regulatory leadership at Curevo by executing Curevo’s Global regulatory plans for one or more pipeline products.  This position leads, develops, and implements preparation of submissions to regulatory authorities for our vaccine programs.

Key Role and Responsibilities

• Development and implementation of domestic and international regulatory strategies and processes to assure the timely global commercialization of our vaccine products in compliance with applicable regulations.
• Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes.
• Prepare, maintain and/or co-ordinate regulatory submissions.
• Assist in preparation for regulatory authority interactions.
• Review Clinical/Non-Clinical documents, Protocols, Methods and test results and provide input.
• Provide tactical regulatory representation on development teams.
• Prepare, maintain and coordinate INDs, CTAs in accordance with applicable regulations.
• Work extensively with contract research organizations for ex-US regulatory submissions.
• Ability to understand and contribute to CMC modules of the IND and CTAs upon requirement.
• Experience with product labeling for US and ex-US markets.

Qualifications

Preferred Education

• BS Degree required, preferably in Biology, Chemistry, Biochemistry, Bioengineering, Biotechnology or related Life Science discipline.
• MS degree preferred.

Preferred Experience

• Eight + years of Clinical Regulatory Affairs experience with a Biotech/Pharma or CRO.  Immunology, Infectious Diseases and/or Vaccine experience preferred.
• Demonstrated ability to file INDs with the FDA and CTAs, MAAs with the EMA.
• Experience developing dossiers, including INDs, BLAs, MAAs, briefing documents, etc.
• Experience creating summaries for clinical pharmacology, efficacy, clinical safety, and non-clinical portions of regulatory submissions.
• Regulatory technical writing (clinically focused) to support development of clinical documents in accordance with ICH/E6/GCP guidelines to support US/EMA submissions, clinical trial applications.
• Strong understanding of 21CFR Part 11 and 12, ICHQ7 and Eudralex Vol. 4.

Knowledge, Skills, and Abilities

• Outcome driven; can thrive in a fast-paced environment with rapid change while effectively managing pressure in a professional manner.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
• Strong technical/analytical skills to identify and solve problems independently.
• Proactively seeks out and recommends process improvements.
• Willingness to work collaboratively.
• Proficiency with MS Office products Word, Excel, PowerPoint, Outlook) and other electronic systems.

Curevo offers its employees a generous range of compensation and benefits.

The salary range for this position is $140,000 to $190,000 annually. The salary range may vary based on Curevo’s compensation practices and an applicant’s qualifications and experience.

Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevo’s Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect.  We have a Flexible Vacation Plan, Paid Sick Leave Plan earning 1 hour of sick time for 30 hours worked, and 10 paid holidays per year.

At Curevo, we believe the highest-performing teams include people from a variety of backgrounds and experiences who respectfully challenge each other and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

About Curevo Vaccine

Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.

Attention: Search Firms / 3rd Party Recruitment Agencies

The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.