Sr Manager, Regulatory Affairs
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 and execute on creative regulatory strategies. As a Sr. Regulatory Manager, you will play a key role in the support of one of our growing Business units and be part of cross functional teams dedicated towards the development of life enhancing drug-device combination products. The position can be located in Gaithersburg, Maryland or Lansing, Michigan with a possible opportunity remote work. Reporting to the Director of Regulatory Affairs, responsibilities for the Regulatory Affairs Sr. Manager include:
- Ensuring that Emergent obtains all licenses required to enable clinical trials (as needed) as well as market commercially approved products.
- Under minimal supervision, establishing and implementing product related regulatory strategies and advising the cross-functional project teams on Regulatory considerations when developing overall strategy for assigned programs.
- 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 general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- Bachelor’s degree in a life sciences or related discipline required.
- 10+ years of industry experience in Regulatory Affairs.
- Must have experience interacting with FDA and 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.
- Regulatory submissions experience
- Cross-functional experience Knowledge and Skills
- Working with policies, procedures and SOP’s
- 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
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.
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.
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Job posted: 2021-02-03