Are you looking for an opportunity where you can use your expertise to provide strategic, technical, and regulatory guidance for clinical development and drug development life cycles? A role where you can lead regulatory consulting services and maintain technical knowledge in product development and international regulatory affairs? If so, we’re hiring a Senior Director of Regulatory Affairs!

About You:

You have 12+ years or more relevant regulatory affairs experience.
You possess a comprehensive understanding of financial management.
You have expertise in all aspects of the drug development process inclusive of regulatory milestones and clinical trials methodology, including a working knowledge of protocols and indications being studied.
You have specialized knowledge of regulatory activities including but not limited to submissions to regulatory authorities, including INDs/CTAs and
amendments, ODDs, and PIPs.
You can understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
You are experienced in pharmaceutical product development and marketing authorizations (MAA/CTAs/INDS/NDA and or BLA/sBLA) experience in filings in an eCTD format.
You are eager to develop, coach, and mentor regulatory team members, ensuring the sharing of best practices across the team.

About the Role:

As a Senior Director of Regulatory Affairs, you are responsible for the provision of high-quality regulatory technical advice and development strategies for clients across a wide range of therapeutic indications and will provide regulatory strategy and leadership for all North America and/or International (inc. European) regulatory submissions. You will lead and support teams and efforts around major filing activities and Health Authority interactions, and will provide regulatory support to other departments, project teams, and committees. In this leadership role, you will support the further development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.

Required:

Post Graduate Degree, bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline
Experience in functional management including experience in delegating while fostering cohesive team dynamics
Computer literacy in MS Office/ Office 365
Availability for domestic and international travel including overnight stays

Who We Are

Precision for Medicine is the first global, precision-medicine, clinical research organization. Purpose-built to shift the development curve for life sciences clients, we incorporate laboratory expertise, clinical trial excellence, and advanced data sciences at every stage. Known as Precision Convergence, this integrated approach enables us to deliver critical insights into patient biology from early development through approval. The result: More predictable trial outcomes. Accelerated clinical development. New life-changing treatments for the patients around the globe.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$150,800—$226,200 USD

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

When autocomplete results are available use up and down arrows to review

+ Add another education

LinkedIn Profile

What is your desired salary? *

Are you authorized to work lawfully in the country/location for which you are applying? *

Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. *

If sponsorship is required, confirm your current visa type:

Have you ever worked for Precision Medicine Group or one of its affiliated companies? *

If yes, when and which company?

Have you ever interviewed with Precision Medicine Group or an affiliated company? *

If yes, when and which company?

Are you currently subject to a Non-Compete or Non-Solicit with your current employer? *

I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or resumes as it relates to the position I am seeking and to the extent permitted by federal, state, or local law. I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States. I also understand that the Company employs only individuals who are legally eligible to work in the United States. This application will remain active for 60 days. Any applicant wishing to be considered for employment after that time must reapply. UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. *

Legal Address - Street Address 1 *

Legal Address - Street Address 2

Legal Address - City *

Legal Address - State *

Legal Address - Zip *

Legal Address - Country *

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 Precision for Medicine’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Are you Hispanic/Latino?

Please identify your race

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.

Veteran Status

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

Disability Status

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.

Our system has flagged this application as potentially being associated with bot traffic. Please turn off any VPNs, clear your browser cache and cookies, or try submitting your application in a different browser. If this issue persists, please reach out to our support team via our help center.

Please complete the reCAPTCHA above.

Senior Director of Regulatory Affairs - Remote US

Apply for this Job

Voluntary Self-Identification

Voluntary Self-Identification of Disability