Sr. Manager, Regulatory Affairs - Combination Products - Remote

Location
Gaithersburg, MD
Posted
Jul 01, 2022
Ref
892030500
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time


 

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.

JOB SUMMARY 
Fully remote Sr. Manager role with Regulatory Affairs Product Development Team. Unique opportunity to work on development of combination products in the MCM space. Define regulatory strategies and lead execution of those strategies as part of dynamic cross functional teams. Participate in all aspects of bringing products through early development to approval.


ESSENTIAL FUNCTIONS
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.
•    Overseeing and leading regulatory submissions (e.g. clinical trial and marketing applications) for Emergent’s drug-device combination products portfolio in compliance with applicable regulatory requirements (US and global).
•    Providing content guidance to cross functional teams for CTAs and market applications  
•    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. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    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
•    Must have regulatory experience in submission of applications for small molecules and/or generics (additional combination product experience preferred) in a development or post approval setting. 
•    Knowledge of national legislation and regulations relating to medicinal products (small molecules, generics, combination products) 
•    Awareness of the registration procedures for enabling clinical trials, obtaining market authorization, and managing post approval changes
•    Knowledge of drug development and/or combination product 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.