11 days old

Manager, Regulatory Affairs

Gaithersburg, MD 20877
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We go where others wont, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

The Manager, RA Advertising and Promotion will support advertising and promotion efforts at across the enterprise at Emergent. The position will develop and communicate RA advertising and Promotion strategy to internal stakeholders, providing regulatory strategy, direction, support and advice to the commercial teams. The position will provide support for regulatory and advertising submissions in collaboration with Regulatory Operations. The position will interact closely with team members from Commercial, Medical Affairs, Marketing, Legal, and Compliance and will represent RA on the various internal Promotional Review Committees.

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

Leading voice for regulatory activities pertaining to the development of promotional and non-promotional material for external use
Review internal communications intended for training, learning and development, and education, as needed.
Provide critical regulatory review of promotional and non-promotional external communications
Prepare promotional labeling and advertising submissions to OPDP/APLB
Work closely with Regulatory Operations to ensure on-time submission of required documents.
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed.
Interact with company partners and consultants for various regulatory matters as needed
Interaction with business unit teams, other functional managers, and internal/external customers
Participate in Regulatory Department initiatives, such as process improvement projects
Other duties as assigned.

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 managements assignment of essential functions.

Bachelors degree in life science field or healthcare-related field is required
Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred
3-5 years of experience in Regulatory Affairs, Advertising and Promotion required
5-7 years of experience in US/global pharmaceutical industry required
Advanced education may substitute years of experience mentioned above
Experience in regulatory submissions required
Strong written and verbal communication skills
Experience with Veeva suite products preferred
Strong interpersonal skills
Is able to direct work as required and manage complexity
Able to anticipate and prevent potential issues
Careful attention to detail and accuracy required
Extensive knowledge of MS Word, Project, PowerPoint, Excel, and other MS Office applications and Adobe Acrobat

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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.


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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.


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


  • Biotechnology
Posted: 2023-05-26 Expires: 2023-06-26

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Manager, Regulatory Affairs

Emergent BioSolutions Inc.
Gaithersburg, MD 20877
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