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Sr Director, Regulatory Affairs

Employer
Emergent BioSolutions
Location
Gaithersburg, MD
Start date
Jul 27, 2022

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Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital
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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.

The Senior Director, Regulatory Affairs (departmental administrator and Regulatory Operational/Process Excellence) will be responsible for several areas within the RA function that provide directional and operational support to the entire global regulatory affairs organization and enterprise business needs. This role works to advance the objectives and vision of the global head of Regulatory Affairs, as well as overseeing the execution of a variety of regulatory initiatives. The scope of this position includes oversight of the regulatory operations team (including publishing and data governance for the RA function), Regulatory Policy and Intelligence, regulatory review of advertising & promotional materials, scientific disclosure and management of regulatory governance setup. The role ensures project management support and facilitation of the Regulatory Affairs Leadership Team with the co-ordination and preparation of the meetings and tracking of required actions until completion. The role requires that the individual be able to contribute both as a leader and as an individual contributor. This role reports directly into the global head of Regulatory Affairs and works with senior leadership to identify key opportunities for optimization within RA and cross-functionally.

 

Essential Functions
•    Provide management and strategic oversight of the following regulatory areas and teams: Regulatory Operations, Regulatory Policy & Intelligence and Advertising & Promotional material review. 
•    Serve as a strategic thought partner to the global head of Regulatory Affairs and Regulatory Affairs Leadership Team with regards to issues, current and future initiatives, strategies, project management and budgets
•    Coordinate Regulatory Affairs Leadership Team meetings, plan agendas and track actions.
•    Lead identified project and budget-related initiatives to support and facilitate the activities of the Regulatory Affairs Leadership team
•    Work closely with Global Head RA, RA staff and cross functional areas to set strategies for management and harmonization of processes & systems and performance indicators
•    Monitor progress towards Regulatory’s KPIs, provides insight in evaluating overall Regulatory Performance over time and for future planning
•    Direct or lead initiatives to optimize or develop cross functional ways of working and governance setup (e.g. building matrix teams) in  support of product development and post license maintenance and ensures compliance with regulatory requirements.
•    Establish and maintain internal and external Regulatory support network (contractors, consultants, CROs, etc) to support the business growth and regulatory resource needs
•    Represent RA on various program and leadership forums as assigned
 

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
•    BS degree in related biological and life sciences field (MS or PhD preferred)
•    15+ years of industry experience in Regulatory Affairs for pharmaceutical products in post licensure settings and multiple phases of development.
•    Project leadership experience in aligning cross-functional teams and driving processes forward.
•    Process improvement expertise and experience desirable (Six sigma, LEAN and/or PMP certification)
•    Exceptional communicator with ability to drive clarity during complexity
•    Demonstrates senior leadership presence and is able to coach and mentor team members to perform at a high level
•    Knowledge of global regulations / guidances and thorough knowledge of drug development process required.
•    Experience in global regulatory processes is highly desired.
 

 

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.

Company

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 www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS

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Find Us
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
United States
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