This job has expired

You will need to login before you can apply for a job.

Sr Manager, Regulatory Affairs - Remote

Emergent BioSolutions
Gaithersburg, MD
Start date
Jul 27, 2022

View more

Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
You need to sign in or create an account to save a job.

Job Details

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

This is an opportunity for an experienced Regulatory professional to work on a diverse and complex portfolio, including a small molecule anti-viral therapeutic, as well as execute on creative regulatory strategies.  As a Sr. Regulatory Manager, you will play a key role in the support of our RA Product Development team and be part of cross functional teams dedicated towards the development of life enhancing drug products.  He/she will work with functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities. The Sr. Manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as leading, planning and executing meetings with regulatory agencies. 

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders, including Clinical, Non-clinical, Medical and R&D.
•    Overseeing and leading regulatory submissions (e.g. clinical trial and marketing applications) for Emergent’s developmental drug products portfolio in compliance with applicable regulatory requirements (US and global)
•    Providing content guidance to cross functional teams for CTAs and market applications
•    Working with cross functional teams to create company core data sheets and develop product labeling  
•    Overseeing, leading, and setting strategies in place for meetings and teleconferences with regulatory agencies
•    Under minimal supervision, identifying potential outcomes and risks associated with interactions and/or correspondence with regulatory agencies.
•    Ensuring regulatory product compliance for product (e.g. agency commitments).
•    Communicating and ensuring alignment with direct management and cross functional team
•    Maintaining an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to assigned programs 
•    Performing regulatory research to obtain relevant histories, precedence, and other information relevant to assigned programs 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 


•    Bachelor’s degree in a life sciences or related discipline required.  Approximately 10+ years of relevant pharmaceutical industry experience, with minimum 5 years in Regulatory Affairs.  Less experience acceptable for suitable candidates with relevant industry experience and skill sets.
•    Must have experience interacting with the FDA, EMA, Health Canada and/or other regulatory agencies
•    Must have experience in developing and executing on advanced and complex regulatory strategies, including integrating Clinical and Non-clinical elements.
•    Previous participation in labeling development.
•    Must have regulatory experience in submission of applications for small molecules in a development or post approval setting
•    Knowledge of national legislation and regulations relating to medicinal products 
•    Awareness of the registration procedures for enabling clinical trials, obtaining market authorization, and managing post approval changes
•    Knowledge of drug development Scientific / Technical Excellence
•    Communication skills – both oral and written
•    Ability to understand and communicate technical and clinical information
•    Ability to anticipate and prevent potential issues
•    Understanding of regulatory activities and their touch points
•    Ability to resolve conflicts and develop a course of action leading to a positive outcome


Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.


Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS


Find Us
400 Professional Drive
Suite 400
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert