Associate Director, US Advertising and Promotion Regulatory Review

4 weeks ago

Exton, Pennsylvania, United States Takeda Pharmaceuticals Full time

Regulatory Affairs Expert for US Advertising and Promotion


Takeda Pharmaceuticals is seeking a highly skilled Regulatory Affairs Expert to join our team in the US Advertising and Promotion department. As an Associate Director, you will be responsible for providing regulatory strategic oversight for complex products or therapeutic area products to ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.


Key Responsibilities:

  • Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
  • Provide regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.
  • Interpret complex issues in relation to regulatory requirements and promotional strategy.
  • Mentor and develop staff. Supervise, train and provide technical and regulatory guidance to staff.
  • Be the chair of promotional review meetings and assist Commercial with the planning and prioritization of proposed promotional and disease state materials.
  • Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, execute and approve key Commercial campaigns. Provide expert guidance to help evaluate and mitigate potential risk.
  • Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
  • Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies.
  • Provide product development and label development strategies to ensure promotional claims can be supported.
  • May provide management of individuals including mentoring, performance management, and staffing decisions. Identifies and proposes solutions to management for any resource gaps for brand responsibilities.
  • Present to senior management and cross-functional teams regarding shared insights from FDA advisory comments, recent enforcement actions, and/or guidance documents.
  • Be a primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for assigned business unit/therapeutic areas.


Requirements:

  • Bachelor's Degree in life science or equivalent required. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
  • Minimum of 5 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience specific to Regulatory Affairs – Advertising and Promotion.
  • Knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
  • Experience in Regulatory Affairs promotion and advertising; experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
  • Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.
  • Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights.
  • Regulatory Affairs Certification (RAC) desirable.


Travel Requirements:


Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.


Requires approximately up to 25% travel.


About Takeda:


Takeda Pharmaceuticals is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.


This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy.


Takeda Compensation and Benefits Summary


We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.


For Location:


Lexington, MA


U.S. Base Salary Range:


$149,234.30


The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.


The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.


U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.


EEO Statement:


Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.


Locations:


Lexington, MA


USA - PA - Exton


Worker Type:


Employee


Worker Sub-Type:


Regular


Time Type:


Full time

  • Regulatory Affairs Expert for US Advertising and Promotion

    3 weeks ago

    Exton, Pennsylvania, United States Takeda Pharmaceuticals Full time

    Role SummaryTakeda Pharmaceuticals is seeking a highly skilled Regulatory Affairs expert to lead our US Advertising and Promotion team. As an Associate Director, you will be responsible for providing regulatory strategic oversight for complex products or therapeutic area products to ensure regulatory compliance of promotional materials.Key ResponsibilitiesBe...

  • Regulatory Project Manager

    1 month ago

    Exton, Pennsylvania, United States West Pharmaceutical Services Full time

    Job SummaryThis Senior Specialist, Regulatory Project Management role is responsible for the management of regulatory affairs projects associated with West's global portfolio of medical devices, combination products, and packaging components. The RPM will work collaboratively with cross-functional teams and lead the regulatory team through all project phases...

  • Executive Director of Surplus Lines Association

    4 weeks ago

    Exton, Pennsylvania, United States Pennsylvania Surplus Lines Full time

    About Us: The Pennsylvania Surplus Lines Association (PSLA) is a non-profit organization that serves as an advisory body under contract with the Pennsylvania Insurance Department. Our mission is to provide extensive training and education to surplus lines licensees, while fostering innovation, integrity, and consumer protection. Position Overview: As the...

  • Strategic Marketing Lead

    3 weeks ago

    Exton, Pennsylvania, United States SPHERIX GLOBAL INSIGHTS US INC Full time

    We are seeking a highly skilled Marketing Director for Growth to join our team at Spherix Global Insights US Inc. This role will be a contributing senior member of the marketing team, focusing on refining and implementing a cohesive strategic marketing plan.The ideal candidate will utilize SEO techniques, paid advertising, social media marketing, and general...

  • Executive Director

    4 weeks ago

    Exton, Pennsylvania, United States Pennsylvania Surplus Lines Full time

    About Us:The Pennsylvania Surplus Lines Association (PSLA) is a non-profit organization that serves as an advisory body under contract with the Pennsylvania Insurance Department. Our mission is to provide education, training, and compliance services to surplus lines licensees.Position Overview:As the Executive Director, you will lead the association's...

  • Marketing Director

    1 month ago

    Exton, Pennsylvania, United States SPHERIX GLOBAL INSIGHTS US INC Full time

    Job OverviewSpherix Global Insights US Inc. is seeking a highly skilled Marketing Lead to join our team. As a key member of our marketing team, you will be responsible for developing and implementing a comprehensive strategic marketing plan to drive brand awareness and profit growth.Key ResponsibilitiesDevelop and execute a cohesive marketing strategy to...

  • Director of Quality Assurance

    1 month ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Director of Quality AssuranceFrontage Laboratories is seeking a highly skilled and experienced Director of Quality Assurance to join our team.Job Summary:The Director of Quality Assurance will play a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and...

  • Director of Quality Assurance

    4 weeks ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryThe Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance.This position is responsible for monitoring manufacturing, packaging, releasing, disposition, testing, and validation activities,...

  • Manufacturing Operations Director

    4 weeks ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    pbJob Title:/b Senior Director of Pharmaceutical Manufacturing/ppbJob Summary:/b/ppFrontage Laboratories Inc. is seeking a Senior Director of Pharmaceutical Manufacturing to lead our manufacturing operations. This role will be responsible for all aspects of manufacturing and packaging operations, including working with R&D scientists, scale up, and Clinical...

  • Portfolio Property Manager

    3 weeks ago

    Exton, Pennsylvania, United States CCR LLP Full time

    Portfolio Property Manager OpportunityCRR Management, Inc. is seeking a skilled Portfolio Property Manager to oversee a diverse portfolio of homeowner associations, condominium associations, and community associations. The ideal candidate will have a strong understanding of investment strategies and financial markets, as well as excellent analytical and...

  • Personal Training Sales Director

    4 weeks ago

    Exton, Pennsylvania, United States Maxx Fitness Clubs Full time

    Job Summary:We are seeking a highly motivated and results-driven Personal Training Sales Director to join our team at Maxx Fitness Clubs. As a key member of our sales team, you will be responsible for driving revenue growth and increasing sales of personal training programs.Key Responsibilities:Sell personal training programs to new and existing membersMeet...

  • Director of Fraud Prevention and Detection

    4 weeks ago

    Exton, Pennsylvania, United States Citadel Full time

    Job SummaryThe Director of Fraud Prevention and Detection will lead the development, implementation, and oversight of Citadel Credit Union's fraud prevention, detection, and recovery program. This role involves identifying, assessing, and mitigating fraud risks across all credit union products and services. The Director will work closely with various...

  • Director of Quality Assurance

    4 weeks ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Summary:The Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance. This position ensures seamless integration with global quality processes.Responsibilities:Manage the quality assurance...

  • Fitness Director

    4 weeks ago

    Exton, Pennsylvania, United States Maxx Fitness Clubs Full time

    Job DescriptionMaxx Fitness Clubs is seeking a highly motivated and experienced Fitness Director to lead our Personal Training Program. The ideal candidate will have a strong background in fitness management, excellent communication skills, and a passion for delivering exceptional customer service.Key Responsibilities:Develop and implement fitness programs...

  • Sales Associate

    4 weeks ago

    Exton, Pennsylvania, United States Walmart Full time

    Job Summary:As a Sales Associate at Walmart, you will be responsible for providing excellent customer service and ensuring customer orders are filled accurately. This role involves walking up to 5 miles each day while fulfilling online customer orders, reviewing customer orders, locating and selecting merchandise on the salesfloor, and dispensing customer...

  • Sales Associate

    3 weeks ago

    Exton, Pennsylvania, United States Lands' End Full time

    Job Summary:Lands' End is seeking a Sales Associate to join our team. As a Sales Associate, you will be responsible for providing exceptional customer service and driving sales by utilizing approved consultative selling practices.Responsibilities:Utilize consultative selling practices to identify customer needs and provide appropriate solutions.Provide...

  • Sales Associate

    4 weeks ago

    Exton, Pennsylvania, United States Lands' End Full time

    Job Summary:As a Sales Associate at Lands' End, you will be part of a talented team that represents the brand to customers by providing exceptional service in a professional, courteous, and helpful manner. This role enhances the customer experience and drives profitable sales by providing product expertise and advanced selling skills. Sales Associates also...

  • Senior Accounting Professional

    4 weeks ago

    Exton, Pennsylvania, United States Blue-Halo Full time

    Accounting Operations ManagerAt Blue-Halo, we are seeking an experienced Accounting Operations Manager to join our team. The successful candidate will be responsible for the development, preparation, analysis, interpretation, and maintenance of all accounting records and financial reports. This includes responsibility for the timely and accurate preparation...

  • Math Learning Center Director

    4 weeks ago

    Exton, Pennsylvania, United States Mathnasium (ID: 5702801) Full time

    Job SummaryWe are seeking a highly motivated and experienced Math Learning Center Director to lead our team at Mathnasium of Exton. As a Math Learning Center Director, you will be responsible for managing and overseeing all aspects of day-to-day operations in the center, including screening, hiring, training, and scheduling employees to effectively provide...

  • EU MDR Marketing Claims Specialist

    3 weeks ago

    Exton, Pennsylvania, United States DEV-X Consulting LLC Full time

    Job DescriptionDEV-X Consulting LLC is seeking a highly skilled Medical Device Marketing Claims Specialist to coordinate the EU MDR program work for claims with other copy review workstreams. The ideal candidate will have experience with Medical Device Experience within EU MDD and/or EU MDR.Key Responsibilities:Coordinate the defined cadence of the EU MDR...