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Director, Regulatory Affairs, US Promotion and Labeling

Posted 22 Jun 2018

Rockland, Massachusetts - United States

Req Id 177986

Details

A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.


You role:

As Director, Regulatory Affairs, Promotion and Labeling, you will be responsible for communicating regulatory policy and working in a collegial manner with a multidisciplinary team. You will also be working with company management on the strategy and efficient execution of field medical communications for scientific exchange of investigational products prior to approval, providing regulatory guidance on disease awareness and coming soon campaigns, and ensuring the comprehensive regulatory review of all types of HCP, consumer, and payer promotional activities for the introduction, launch, and early LCM of EMD Serono marketed products and services in a highly competitive therapeutic area.

You will interact with senior leaders and cross-functional colleagues in the US and global organizations to maximize the success of a new launch in the near-term. This role is key to providing direction, content review for internal, training, non-branded and branded materials, and will be responsible for interaction with FDA’s Office of Prescription Drug Promotion and interpretation of FDA regulations and guidance documents. You will independently represent the Regulatory compliance voice on such matters and serve as the internal expert to advise the team locally and globally on the FDA requirements while working collaboratively with stakeholders to reach consensus on approved messages and materials in an efficient and effective manner.

As Director you will be well-versed in the company core data sheet, competitive labeling requirements, and marketing practices, and provide regulatory direction and oversight for new or revised data-driven US product labeling and packaging artwork in collaboration with local and global disciplines and external parties and serve as the expert for the regulatory history for labeling and promotional communications with FDA. In this role you or a direct report will serve as a member of the Regulatory Subteam to the Global Project Team for late stage products and support phase 4 study initiatives. Additional responsabilities: 

  • Providing regulatory direction in the development and approval of compliant advertising and promotional materials, disease state education, field training materials, and external communications
  • Mentoring others to aid in their growth and development as Regulatory professionals.
  • Maintaining a thorough understanding of OPDP requirements as well as a keen awareness of enforcement trends and is confident in their analysis and application to compliance assessments
  • Preparing presentations and train other departments and outside speakers 
  • Engaging with key stakeholders and teams in the creation and execution of FDA compliant programs for product sampling, speaker events, medical congresses, launches, market research and competitive analysis. 
  • Leading efforts to create, modify, and review labeling documents, including prescribing information, patient labeling, and packaging/artwork content and device instructions for use with attention to competitive positioning 
  • Be responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in medical and marketing communications and activities
  • Attending domestic and international meetings and events to support the communication and development of scientific and commercial messages with real time, on-site regulatory direction and oversight
  • Working collaboratively with local and global colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during promotional and scientific medical reviews 
  • Serving as the primary point of contact with the FDA Office of Prescription Drug Promotion on all matters and oversee 2253 material submissions 
  • Leading US Labeling Working Group for new product labeling and works closely with the Global Labeling Team on alignment with the Company Core Data Sheet. Co-ordinate response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts 
  • Providing analysis of competitor labeling in the relevant therapeutic area 
  • Be responsible for continuous quality and compliance throughout the packaging labeling process 
  • Be a member on project teams and regulatory sub-teams, as appropriate 
  • Preparing SOPs, work instructions and provides related training presentations and Q&A sessions

Who you are: 

  • Graduate degree in regulatory, legal, or a life sciences or similar experience and training
  • Managerial and supervisory experience
  • Minimum of 15 years pharma industry experience with late stage or marketed prescription products and LCM activities with at least 8 years in US Regulatory Affairs promotion and 2 years in labeling strategy
  • Experience with combination (i.e., drug/device or biologic/device), biologics or drug products and neurology/CNS is preferred. A working understanding of registration dossier content (IND, NDA/BLA MAA, eCTD) is a plus.
  • Ability to prioritize, collaborate, and efficiently multi-task projects independently in a results-oriented collegial manner is required
  • Strong organizational, interpersonal and written/verbal communication skills are required
  • Ability to travel domestically and internationally is required. About 10-15%

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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