Summary:

The Exec Dir / VP, Regulatory Affairs will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for the assigned product in a specific indication. The ED/VP is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This role will participate as a core project team member and will manage personnel that prepare the regulatory submissions and interact with Core Team members, agencies/health authorities to obtain and maintain product approvals.

Essential Duties and Responsibilities

  • Develop and implement regulatory strategy for assigned projects.
  • Regulatory Affairs representatives for Project Team.
  • When assigned, supervise one or more Regulatory Affairs staff, be responsible for their professional development and support their outputs as defined by departmental goals and deliverables.
  • Serve as the primary interface for FDA on assigned projects.
  • Communicate project regulatory strategies and plans to management, cross functional teams and any partners/collaborators to establish alignment.
  • Lead the preparation of regulatory submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications etc.
  • Work with functional groups to define contribution for submissions.
  • Prepare company team for FDA and other health agency meetings, as required.
  • Serve as the primary interface with CROs for coordination and preparation of Health Authority submissions.
  • Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance’s, and current industry practice.
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.

JOB QUALIFICATIONS

  • Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 15+ years pharmaceutical industry experience, including 10+ years in Regulatory Affairs.
  • Experience in multiple phases of development in relevant therapeutic areas. Experience in pulmonary and cardiovascular diseases a plus.
  • Significant experience in drug development including product approval/launch.
  • Demonstrated experience in preparing FDA submissions including NDAs or BLAs and experience with global dossiers. Experience with eCTD content and format for regulatory submissions.
  • Knowledge of the drug development process and global submission process.
  • Knowledge of global regulatory requirements as they relate to the overall global regulatory strategy.
  • Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
  • Prior experience with drug/device combinations products
  • Proven ability to build partnerships with senior key stakeholders from other functions to ensure that the strategic business goals are met through sharing of knowledge and expertise.
  • Domestic and occasional international travel required (20%).

 Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

The expected US salary range for this position is $245,000 to $320,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.  This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/

Vaccination Policy:  Gossamer Bio is committed to complying with federal, state and local law on vaccinations.  Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller.

Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment.  Controller’s Privacy team can be contacted at privacy@gossamerbio.com.  

Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes.  Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.   

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted.  You also have to right to data portability.  In addition, you may lodge a complaint with a supervisory authority.

Apply for this Job

* Required
resume chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
When autocomplete results are available use up and down arrows to review
+ Add another education
+ Add another employment

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Gossamer Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.