Current jobs related to Sr. Manager, Regulatory Affairs Advertising - Gaithersburg - BioSpace, Inc.

  • Regulatory Affairs Manager

    1 month ago

    Gaithersburg, Maryland, United States Fladger Assoc. Inc. Full time

    Job Title: Associate Regulatory Affairs ManagerWe are seeking an experienced Associate Regulatory Affairs Manager to join our team at Fladger Assoc. Inc. in Gaithersburg, MD. As a key member of our regulatory affairs team, you will play a pivotal role in ensuring compliance with regulatory requirements and facilitating the development and approval of our...

  • Director of Regulatory Affairs

    2 weeks ago

    Gaithersburg, MD , USA, United States Proclinical Staffing Full time

    Director, Global Regulatory Affairs, Development StrategyProclinical is seeking a seasoned professional to lead our client's global regulatory affairs and development strategy efforts.Key Responsibilities:Develop and implement a comprehensive US regulatory development strategy to ensure successful registration and life-cycle management of complex...

  • Director, Global Regulatory Affairs, Development Strategy

    4 weeks ago

    Gaithersburg, Maryland, United States Proclinical Staffing Full time

    Director, Global Regulatory Affairs, Development Strategy – Permanent – MA or MDProclinical is seeking a Director, Global Regulatory Affairs, Development Strategy for a global biotechnology company with locations in Massachusetts and Maryland.Key Responsibilities:Develop and implement US regulatory development strategy leading to successful registration...

  • Director of Regulatory Affairs

    2 weeks ago

    Gaithersburg, MD , USA, United States Proclinical Staffing Full time

    Job Title: Director, Global Regulatory Affairs, Development StrategyProclinical Staffing is seeking a highly skilled Director, Global Regulatory Affairs, Development Strategy to join our team. As a key member of our organization, you will be responsible for developing and implementing US regulatory development strategies to ensure successful registration and...

  • Senior Scientific Affairs Executive

    4 days ago

    Gaithersburg, Maryland, United States American Red Cross Full time

    Scientific Affairs Executive RoleThe American Red Cross is seeking a highly skilled Scientific Affairs Executive to lead our research and development efforts in infectious disease. As a key member of our team, you will be responsible for determining direction and establishing priorities for product development, including demonstrating new or improved...

  • Senior Vice President, Medical Affairs

    4 days ago

    Gaithersburg, Maryland, United States Miltenyi Biotec Full time

    Job DescriptionAre you a seasoned professional looking to make a meaningful impact in the biopharmaceutical industry? Miltenyi Biomedicine is seeking a highly skilled and experienced leader to join our team as a Vice President, Commercial Strategy.About the RoleWe are looking for a strategic thinker with a proven track record of launching hemato-onco...

  • Vice President of Scientific Affairs

    4 weeks ago

    Gaithersburg, Maryland, United States American Red Cross Full time

    Transform Lives with a Career in Scientific AffairsWe are seeking a highly skilled and experienced professional to join our team as Vice President, Scientific Affairs. In this critical role, you will be responsible for leading our research and development efforts, driving innovation, and advancing our scientific expertise.Key Responsibilities:1. Oversee the...

  • Vice President of Scientific Affairs

    3 weeks ago

    Gaithersburg, Maryland, United States American Red Cross Full time

    Unlock Your Potential in Scientific AffairsAre you a visionary leader with a passion for scientific innovation? Do you have a track record of driving research and development in infectious disease? We're seeking a talented Vice President of Scientific Affairs to join our team at the American Red Cross.About the RoleAs a key member of our leadership team, you...

  • Assistant Community Manager

    4 days ago

    Gaithersburg, MD , USA, United States Acento Advertising Full time

    Acento Real Estate Partners is a dynamic and innovative company that specializes in value-driven investment management strategies and property management services. We are seeking an Assistant Community Manager to join our team at Governor Square in Gaithersburg, Maryland.Key Responsibilities:Collect and post rent each monthAssist in handling resident work...

  • Sr. Accountant

    1 week ago

    Gaithersburg, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are offering a short term contract employment opportunity for a Sr. Accountant in Gaithersburg, Maryland. The job function will involve handling various accounting duties in a fast-paced environment. As a Sr. Accountant, you will be involved in various aspects of accounting, including reconciliations, journal entries, and...

  • Senior Commercial Leader for CAR-T Therapies

    2 weeks ago

    Gaithersburg, Maryland, United States Miltenyi Biotec Full time

    Job DescriptionAs a Senior Commercial Leader for CAR-T Therapies, you will be responsible for the successful launch and long-term success of Miltenyi Biomedicine's CAR-T product in the US market. This role will lead a senior-level cross-functional launch team, including Market Access, Sales, Medical Affairs, Business Operations, Trade, and will develop...

  • Client Oncology Sr. RWE Data Scientist

    5 months ago

    Gaithersburg, United States Sunrise Systems Full time

    Client Oncology Sr. RWE Data Scientist Job Description Do you have expertise in, and passion for Medical Affairs in Oncology? Would you like to apply your expertise to impact the Associate Director/ Sr. RWE Data Scientist role in a company that follows the science and turns ideas into life changing medicines? Then Client might be the one for you! At...

  • Senior Vice President, Biomedicine Commercial Strategy

    4 days ago

    Gaithersburg, Maryland, United States Miltenyi Biotec Full time

    Are you ready to revolutionize the personalized medicine landscape? Miltenyi Biomedicine, a division of the Miltenyi Group, is at the forefront of bringing customized cancer treatments and regenerative therapies to patients worldwide. As a key member of our commercial team, you will play a pivotal role in bridging the gap from laboratory bench to patient...

  • Senior Vice President, Biomedicine Commercial Lead

    2 weeks ago

    Gaithersburg, Maryland, United States Miltenyi Biotec Full time

    Job Title: Senior Vice President, Biomedicine Commercial LeadAre you ready to revolutionize the personalized medicine landscape? Miltenyi Biomedicine is a pioneering division of the Miltenyi Group, dedicated to bringing cutting-edge cancer treatments and regenerative therapies to patients worldwide.As our Senior Vice President, Biomedicine Commercial Lead,...

  • Associate Director, Brand Communications

    5 months ago

    Gaithersburg, United States AstraZeneca Full time

    AstraZeneca is leading a revolution in oncology to redefine cancer care. We have a bold ambition to one day eliminate cancer as a cause of death. We are looking for an Associate Director of Brand Communications to join us as a core member of the US Oncology Corporate Affairs team while collaborating with other teams across AstraZeneca. This role will lead...

  • VP, Biomedicine Commercial Lead

    4 weeks ago

    Gaithersburg, Maryland, United States Miltenyi Biotec Full time

    Job Title: VP, Biomedicine CommercialAt Miltenyi Biomedicine, we are seeking a highly experienced and strategic VP, Biomedicine Commercial to lead the commercialization of our CAR-T product in the US market. As a key member of our leadership team, you will be responsible for developing and executing a comprehensive commercial strategy, building a...

  • Director External Scientific Engagement

    4 months ago

    Gaithersburg, United States AstraZeneca Full time

    Introduction to Role: Are you ready to take the lead in providing strategic direction, specialist medical education knowledge, and leadership of the CVRM Medical Education programs? As the Director of External Scientific Engagement, you will work across the BioPharmaceutical Cardiovascular, Renal and Metabolism (CVRM) organization. This is your chance...

  • VP, Medical Director

    4 weeks ago

    Gaithersburg, Maryland, United States Miltenyi Biotec Full time

    Join Our Team as a VP, MedicalWe are seeking a highly skilled and experienced VP, Medical to lead our commercial efforts in the US market. As a key member of our leadership team, you will be responsible for developing and executing a comprehensive commercial strategy for our CAR-T product.Key Responsibilities:Develop and execute a go-to-market plan for our...

  • Safety Manager

    2 weeks ago

    Gaithersburg, Maryland, United States ESFM Full time

    Job Opportunity: Safety CoordinatorESFM, a leading provider of integrated facilities management services, is seeking a highly skilled Safety Coordinator to join our team.Job Summary:The Safety Coordinator will play a critical role in ensuring the safety and well-being of our employees, clients, and customers. This position will be responsible for developing...

  • Global Oncology Publications Director

    5 days ago

    Gaithersburg, Maryland, United States Fladger Assoc. Inc. Full time

    Job Title: Global Oncology Publications DirectorJob Summary:We are seeking a highly experienced Global Oncology Publications Director to lead our cross-functional team in delivering the strategic publications plan for our oncology franchise. The ideal candidate will have a strong background in medical affairs and publications, with a proven track record of...

Sr. Manager, Regulatory Affairs Advertising

5 months ago

Gaithersburg, United States BioSpace, Inc. Full time
Job Details

We go where others won't, 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.

JOB SUMMARY
The Senior Manager RA Advertising and Promotion will help support advertising and promotion efforts across the enterprise at Emergent. The position will lead in developing and communicating RA Advertising and Promotion strategy to internal stakeholders, providing regulatory strategy, direction, support, and advice to the commercial teams. 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.

ESSENTIAL FUNCTIONS
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.
Establish and collaborate on development of internal processes, standards and best practices to ensure promotional compliance and quality.
Provide training to other functions on Health Authority requirements.
Monitor corporate activities for regulatory compliance.
Provide critical regulatory review of promotional and non-promotional external communications.
Preparation of 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.
Present to Sr Management and drive decisions on complex material.
Interact with company partners and consultants for various regulatory matters as needed.
Interact 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 management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelor's degree in life science field or healthcare-related field is required
Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred
5-7 years of experience in Regulatory Affairs, Advertising and Promotion required; manager experience preferred
8-10 years of experience in US/global pharmaceutical industry required
Experience in global regulatory affairs (EU, Canada) preferred
Experience in regulatory submissions required
Biological and vaccine product experience preferred
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.