Senior Manager Regulatory Affairs

Remote

Full Time

Senior Manager/Supervisor

PharmaLex is one of the largest providers of Development Consulting & Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech, and MedTech industries, helping them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.

We are currently looking for an experienced Senior Manager to support our Regulatory Affairs Team. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
PharmaLex is proud to be an equal opportunity employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skills, and experiences within our workforce. We believe that diversity and inclusion among our teammates are critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

Key Responsibilities and Activities

Act as a key regulatory affairs consultant, providing expertise and innovative solutions to clients and internal teams on US and Canadian regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications.
Develop and drive execution of short and long-term regulatory strategies and translate into tactical operational plans for execution.
Lead cross-functional submission teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy.
Ensure timely preparation, review, and submission of documents to regulatory authorities, and ensure compliance with applicable regulatory requirements.
Coordinate, prioritize and track regulatory activities and submissions associated with clients’ research, development, and post-marketing activities for a variety of therapeutic areas.
Manage budgets, client expectations, and project delivery for global projects.
Prepare Module 1 documentation for US and Canadian Regulatory filings.
Maintain knowledge of changing regulatory requirements and advise teams as appropriate (Regulatory Intelligence).
Represent client regulatory affairs team as needed.
Identify potential regulatory risks to the operational plans and propose options to mitigate risks.
Draft and manage regulatory submissions, such as new INDs, IDEs, annual reports, Investigator's Brochure, clinical and nonclinical protocols, NDA/ANDA/BLA, MAAs, and other submissions as required.
Liaise with regulatory authorities on behalf of clients (e.g., US Agent).
Build, develop, maintain, and expand working relationships with clients.
Support marketing, business development and sales activities to drive new business through proposal writing, pricing, budget estimates, presentations, etc.
Oversee Regulatory Affairs project forecast, budget, scope, and resources.
Assist to continually improve North American Regulatory Affairs processes.
Supervise, guide and train junior staff.

Additional labeling expertise is a plus:

Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, USPI, SPC and their associated Patient Labelling Documents. Manage complex labeling projects (e.g., development labeling for NCEs and NMEs).
Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be incorporated into CLDs worldwide.

Required Education, Experience, Skills and Competencies

5+ years of experience and broad knowledge in the field of Regulatory Affairs, especially generics, prescription drugs and biologics (food, dietary supplements and veterinary drugs experience is a plus).
Experience with planning, preparing, and filing FDA IND/ANDA/NDA/BLA original applications, IND/ANDA/NDA/BLA maintenance submissions, HC CTA/IMPD/NDS.
Good understanding of the North American regulatory landscape, especially Health Authority regulations, guidance documents, processes, and timelines.
Experience with US labeling is a plus.
Strong critical thinking and leadership skills.
Results focused approach and strong sense of responsibility.
Strong work ethic and proven adaptability to meet client needs.
Structured, analytical, systematic, focused, and able to deliver high-quality work.
Strong command of the English language and excellent written, verbal and presentation communication skills.
Ability to work in a growing, fast-changing environment and adapt to resource and knowledge gaps in client and internal RA teams.
Ability to work in a team. Ability to adapt under regularly changing conditions.
Work with client to resolve issues/problems, responding to requests in a timely manner.
Manage client relationship when there are changes in scope or the project plan.
Maintain meaningful relationships with clients after project is completed, keeping PharmaLex business development apprised.
Actively seek out new client relationships/new business opportunities on behalf of PharmaLex.

*This is a remote opportunity
*Travel up to 5%

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

Apply for this position

Required*

Apply with

First Name*

Last Name*

Email Address*

Phone*

Address

Resume*

We've received your resume. Click here to update it.

Attach resume or Paste resume

Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

What's your citizenship / employment eligibility?

Desired salary

Earliest start date?

Do you reside are planning to relocate to in any of the following zip codes:

•94102 • 94103 • 94104 • 94105 • 94107 • 94108 • 94109 • 94110 • 94111 • 94112 • 94114 • 94115 • 94116 • 94117 • 94118 • 94121 • 94122 • 94123 • 94124 • 94127 • 94129 • 94130 • 94131 • 94132 • 94133 • 94134 • 94138 • 94142 • 94143 • 94144 • 94145 • 94146 • 94147 • 94151 • 94158 • 94159 • 94160 • 94161 • 94163 • 94164 • 94172 • 94177 • 94188 **

Have you ever applied or interview for any positions for Phlexglobal, Pharmalex, or Cencora in the past? If so, please enter the position(s) and date(s).*

Are you authorized to work in the US?

Please explain why you are seeking new job opportunities.*

Please explain your experience and the number of years that you have in Regulatory Affairs.*

Please describe your experience with initial marketing applications to FDA (ANDA, NDA and BLA submissions).*

Please provide details on your project management experience*

Please explain your experience with development, review or delivery of product labeling.*

What are your pay expectations? Please provide a dollar amount or range. *Please avoid “negotiable”.*

What is your notice period and/or available start date?*

Is there anything else relevant to the role you would like to share, not covered above, or captured in your CV?*

The following questions are entirely optional.

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.

Gender

Race/Ethnicity

Invitation for Job Applicants to Self-Identify as a U.S. Veteran

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

I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE
I AM NOT A PROTECTED VETERAN
I DON’T WISH TO ANSWER

Voluntary Self-Identification of Disability

Voluntary Self-Identification of Disability Form CC-305
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

Please check one of the boxes below:

YES, I HAVE A DISABILITY, OR HAVE HAD ONE IN THE PAST NO, I DO NOT HAVE A DISABILITY AND HAVE NOT HAD ONE IN THE PAST I DO NOT WANT TO ANSWER

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.

You must enter your name and date
Name	Date

Human Check*

Submit Application