CONTRACT Director Advertising and Promotion

Regulatory Affairs Waltham, Massachusetts


Description

Our growing Regulatory Team needs an experienced Director level Consultant.

Leading, initiating, reviewing and approving strategies for non-promotional and promotional materials to comply with regulatory requirements worldwide throughout the product life-cycle.  The candidate will be responsible for ensuring compliance with regulatory agencies requirements and meeting Apellis’ strategic promotional and corporate communications objectives.  Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new regulations and guidance documents. Will coordinate regulatory training of commercial and marketing teams on regulatory issues pertaining to advertising, promotion, and product launch activities.  The incumbent will work collaboratively with medical affairs, legal compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for Apellis’ product portfolio that support the achievement of business objectives.  Will provide insight, sound judgment and clear directions on promotional programs and tactics that are compliant with regulations and company policies.

Specific Roles and Responsibilities:

  • Maintain a deep and current awareness of evolving US and global regulations and guidelines, enforcement actions and policy issues affecting the pharmaceutical/biotech Industry
  • Provide regulatory input into the development, review, approval, and implementation process for promotional and non-promotional materials review in a cross-functional environment
  • Effectively partner with Medical Affairs, Legal Compliance, Commercial, and other stakeholders as needed to ensure that promotional and non-promotional materials and are reviewed in a timely fashion throughout the product life-cycle
  • Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management
  • Ensure communications and promotional claims are consistent with product registrations, applicable laws, regulations and policies and have sufficient substantiating evidence on file
  • Undertake and coordinate regulatory training of Apellis personnel on regulatory issues pertaining to advertisement and promotion activities.

Qualifications and Requirements:

  • Doctorate, Master's, or Bachelor's degree in a life science field (graduate degree preferred)
  • 6+ years’ experience in pharmaceutical or biotech industry in multiple phases of development. with a minimum of 4 years Regulatory Affairs experience in advertising and promotion Experience working with FDA, EMA, and ideally other regulatory authorities worldwide
  • Thorough knowledge of US and EU regulatory requirements and all other global regions pertaining to marketing authorization filings for new products or updates to existing products
  • Extensive knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to FDA, EU and international Requirements
  • Ability to work in a fast-paced, technically challenging environment where drive is critical to success
  • Proficient computer skills; able to use standardized office software products, such as Microsoft Word, Excel, PowerPoint, SharePoint, SmartSheets etc.
  • Effective interpersonal skills with strong organizational skills
  • Ability to effectively communicate and coordinate discussions to influence across all business functions in order to reach resolution
  • Strong writing, project management and communication skills
  • Other duties as required.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.