20 Best director of regulatory affairs jobs (Hiring Now!)

Regulatory Affairs Manager
SIGA Technologies, Inc. —Corvallis, OR
Plan and coordinate documentation/data for regulatory with a primary focus on non-clinical or clinical submissions, while assisting with quality submissions.
$115,000 - $125,000 a year
Quick Apply
Director, Assistant General Counsel
Transmedics Inc —Andover, MA
Collaborate with cross-functional stakeholders to develop policies and procedures to ensure legal compliance across the company.
Estimated: $147K - $187K a year
Quick Apply
Executive Director
Brookdale Danville Piedmont —Danville, VA
Must have a valid driver’s license and access to a private vehicle for business use. Must have a valid administrator license in states where required.
$75,000 - $86,690 a year
Senior Director of Quality, Regulatory and Clinical Affairs
Waters Corporation —Milford, MA
Works to develop annual budgets and manages the budget to ensure appropriate spend to meet financial requirements.
Estimated: $187K - $236K a year
17h
Food Safety Quality Regulatory Manager
Michael Foods Inc. —Hopkins, MN
Must have proficiency with computer skills (such as Microsoft Office suite); experience developing and maintaining user databases for technical information and…
Estimated: $86.4K - $109K a year
Medical Technician - Overnights
High Watch Recovery Center —Kent, CT
Provides direct care services to include monitoring guests’ vitals and progress of detoxification. Certified Nursing Assistant, Emergency Medical Technician or…
Estimated: $40K - $50.6K a year
Quick Apply
13d
Regulatory Affairs and Compliance - Houston, Texas (Utilities/Retail Energy Industry)
Spark Energy, L.P. —Houston, TX
Bachelor’s degree in Political Science, Communications, Business, or related field required. 3+ years’ experience in a compliance or regulatory role in the…
Estimated: $82.4K - $104K a year
Director, Regulatory Affairs
X4 Pharmaceuticals INC —Boston, MA
Bachelor’s degree required, ideally in a science-related field; advanced degree, e.g., Ph.D., preferred. Deep knowledge of guidelines and regulations required…
Estimated: $174K - $220K a year
Quick Apply
1d
Director, Regulatory & Customer Compliance
Michael Foods Inc. —Hopkins, MN
Experience working with federal and state agencies in food manufacturing organizations. Bachelor’s degree in business or a related field.
Estimated: $106K - $135K a year
Ministry Childcare Director
Realife STEAM Academy —Greenfield, IN
Lead, support, and develop all team members through observation, coaching and evaluation designed to develop and deepen early childhood content knowledge and…
$53,000 - $58,000 a year
Quick Apply
Regional Manager, Accreditation and Regulatory Affairs
Inspira Health —Mullica Hill, NJ
Specialize in current concepts of performance improvement and regulatory agency requirements, develop criteria and utilize data analysis techniques and…
Estimated: $91.6K - $116K a year
Quick Apply
Director, Companion Diagnostics Leader
Daiichi Sankyo, Inc. —Basking Ridge, NJ
Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical…
Estimated: $191K - $242K a year
Director of Regulatory & Scientific Affairs H&W NA
Archer Daniels Midland Company —Kennesaw, GA
According to the metrics and KPIs established by H&W and RSA, own trending and root cause analysis of NA’s KPIs and implements actions to ensure a positive…
Estimated: $110K - $139K a year
Director of Procurement
Rapid Reliable Testing, LLC —New York, NY
As a key member of the leadership team, the Senior Director of Procurement will play a pivotal role in managing the company's procurement strategy, driving cost…
$140,000 - $150,000 a year
Quick Apply
20h
Associate Director, Regulatory Affairs
Cytokinetics —South San Francisco, CA
Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provide…
$162,000 - $198,000 a year
Director, Statistical Programming
Daiichi Sankyo, Inc. —Basking Ridge, NJ
Bachelor's Degree an accredited institution in a science or in a technical field preferred. Global Biostatistics Data Management (BDM) Strategy to Improve Drug…
Estimated: $181K - $230K a year
Director of Sustainability
Coca-Cola —Atlanta, GA
Influence and shape technical sustainability investment plans including complex analysis of cost, infrastructure (e.g.: collection and recycling) developments,…
Estimated: $111K - $141K a year
9d
CEO for Psychiatric Hospital in Ohio
Oglethorpe, Inc. —Middle Point, OH
An advanced knowledge of state and federal regulatory and various accreditation requirements related to behavioral health management.
Estimated: $63.2K - $80K a year
Quick Apply
Safety Compliance Specialist
Pete Lien & Sons, Inc —Rapid City, SD
This role will ensure compliance with federal, state, and local safety regulations. Responsibilities include site audits, preparing and submitting compliance…
Estimated: $58.3K - $73.8K a year
Associate Director / Director, Global Regulatory Affairs (Contract)
ImmPACT Bio —Remote
Interpret global regulations and guidance to identify risks and develop regulatory strategy for early-stage cell therapy products through product licensure.
$107 - $150 an hour
Quick Apply

I want to receive the latest job alert for director of regulatory affairs

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Regulatory Affairs Manager

SIGA Technologies, Inc. - Corvallis, OR

Quick Apply

Job Details

Full-time $115,000 - $125,000 a year

Benefits

Health savings account
AD&D insurance
Disability insurance
Relocation assistance
Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
Employee discount
Professional development assistance
Life insurance
Referral program

Qualifications

Microsoft Word
Clinical research
Writing skills
Maintenance
Microsoft Office
Bachelor's degree
Clinical trials
1 year
Research & development

Full Job Description

SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Regulatory Affairs Manager to join our growing Regulatory Affairs team in Corvallis, Oregon. This role is a direct report to the Senior Director of Regulatory Affair and is accountable for the effective management of regulatory activities associated with the development, registration and maintenance of assigned products predominantly in the United States, Canada, Europe, and United Kingdom. The Regulatory Affairs Manager is responsible for coordinating and preparing applications and regulatory filings, assisting in the development of regulatory strategies, and participating in project teams by providing regulatory insight. The incumbent will also be a back-up liaison with the FDA and other regulatory agencies for assigned projects and may require travel both domestically and internationally up to 10% of the time. As a full time (40 hours/week) position, this role is eligible for SIGA’s full benefits package including company paid medical, dental, and visions benefits, short and long-term disability, life/AD&D insurance and paid time off. This position is eligible for a hybrid work arrangement or remote employment for well qualified candidates.

Responsibilities for this position include:

· Work directly with the Senior Director of Regulatory Affairs and other project team members in determining and preparing global regulatory strategies for the development and approval of products.

· Provide input on regulatory issues relating to developmental and post-marketing conditions.

· Plan and coordinate documentation/data for regulatory with a primary focus on non-clinical or clinical submissions, while assisting with quality submissions.

· Prepare submissions of registration documents (INDs, NDAs, etc.). Review material for completeness, internal consistency with other documents, and conformance to applicable agency regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compiles high quality submissions that meet all applicable regulatory requirements.

· Provide regulatory input and advice on the creation, implementation, and revision of SOPs.

· Keep abreast of current regulatory environment in the U.S. and other applicable markets.

· Performs other duties and special projects as assigned

Minimum Qualifications include:

Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent with at least seven years of biotech or pharmaceutical industry experience including five years of increasing regulatory affairs experience.

Demonstrated experience with Microsoft Office Suite with a strong proficiency in Microsoft Word.

Knowledge of biotech R&D, regulatory processes, and clinical trials.

Demonstrated experience writing/preparing regulatory submissions.

The successful candidate will possess the following knowledge and abilities:

· The successful candidate will have experience in the preparation, assessment, and submission of regulatory filings in the U.S. and preferably experience in European, UK, and/or Canadian submissions. eCTD submission/maintenance experience a plus.

· The ability to function in a fast-paced, high-growth, entrepreneurial environment.

· Strong, professional interpersonal skills including ability to communicate effectively with people both individually and in groups.

· Must be able to maintain a high level of confidentiality and manage sensitive situations with tact, professionalism and diplomacy.

· Good working knowledge of regulatory affairs, drug development, and clinical requirements. Preclinical requirements knowledge a plus.

· Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines.

· Experience with antiviral or anti-infective drugs a plus.

· Is a team player who can work flexibly and enthusiastically within a small business environment.

About SIGA:

SIGA Technologies, Inc. is a public, commercial-stage pharmaceutical company focused on providing solutions for unmet needs in the health security market that comprises medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases. The company is headquartered in New York City, with research and development facilities in Corvallis, Oregon. In July 2018, the U.S. Food and Drug Administration (FDA) approved SIGA’s first product, oral TPOXX® (tecovirimat), for the treatment of smallpox. Oral TPOXX is a novel small-molecule drug that has been delivered to the U.S. Strategic National Stockpile (SNS) under the Project BioShield Act of 2004 (Project BioShield).

SIGA offers a challenging, growth-oriented environment with competitive compensation and a full benefits program.

SIGA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity, sexual orientation, marital status, age, national origin, predisposing genetic characteristics, unemployment status or veteran’s status and will not be discriminated against on the basis of disability.

Job Type: Full-time

Pay: $115,000.00 - $125,000.00 per year

Benefits:

401(k)
Dental insurance
Employee assistance program
Employee discount
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Professional development assistance
Referral program
Relocation assistance
Tuition reimbursement
Vision insurance

Schedule:

8 hour shift
Monday to Friday

Supplemental pay types:

Bonus opportunities

Application Question(s):

Briefly describe your experience working on drug applications (writing and/or submitting).

Education:

Bachelor's (Required)

Experience:

Pharmaceutical Regulatory Affairs: 5 years (Required)
Clinical Research Regulatory Affairs: 1 year (Required)

Willingness to travel:

25% (Required)

Work Location: Hybrid remote in Corvallis, OR 97333

Quick Apply

director of regulatory affairs jobs

Regulatory Affairs Manager

Director, Assistant General Counsel

Executive Director

Senior Director of Quality, Regulatory and Clinical Affairs

Food Safety Quality Regulatory Manager

Medical Technician - Overnights

Regulatory Affairs and Compliance - Houston, Texas (Utilities/Retail Energy Industry)

Director, Regulatory Affairs

Director, Regulatory & Customer Compliance

Ministry Childcare Director

Regional Manager, Accreditation and Regulatory Affairs

Director, Companion Diagnostics Leader

Director of Regulatory & Scientific Affairs H&W NA

Director of Procurement

Associate Director, Regulatory Affairs

Director, Statistical Programming

Director of Sustainability

CEO for Psychiatric Hospital in Ohio

Safety Compliance Specialist

Associate Director / Director, Global Regulatory Affairs (Contract)

Job Seeker Tools

Employer Tools

Browse

Stay Connected