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Sr Manager, Regulatory Affairs - Combination Products

Location: 

Lansing, MI, US, 48906 Gaithersburg, MD, US, 20879


 

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 
This is an opportunity for an experienced Regulatory professional to work on a diverse and complex portfolio and execute on creative regulatory strategies.  As a Sr. Regulatory Manager, you will play a key role in the support of our RA Development team and be part of cross functional teams dedicated towards the development of life enhancing drug-device combination 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.


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 must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Lansing