Director Labeling, Advertising and Promotion

Regulatory Affairs Waltham, Massachusetts


Description

Position Summary:

The Director, Regulatory Labeling and Advertising/Promotion will be responsible for leading the development and maintenance of product labeling documentation and reviewing advertising and promotional materials.  The candidate will be responsible for ensuring compliance with regulatory requirements and meeting Apellis’ strategic messaging objectives.  Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new regulations, guidance documents, and enforcement letters.

Specific Responsibilities:

  • Lead the development, review, approval, and implementation process for company core data sheets, regional labels, and other labeling documents in a cross-functional environment
  • Provide guidance to product labeling review teams regarding label development and maintenance
  • Maintain current expertise regarding global labeling requirements, guidelines, and regulations
  • Participate in labeling negotiations with regulatory agencies resulting in product approvals or labeling updates; and release of labeling for use throughout the company
  • Provide regulatory input into review of promotional and non-promotional materials intended for distribution outside Apellis (eg conference presentations, press releases, marketing materials); represent Regulatory Affairs on internal review committees
  • Provide training for commercial and marketing groups within Apellis on regulatory issues pertaining to advertisement and promotion activities
  • Work with Regulatory Affairs strategists and Regulatory Operations to ensure appropriate submission of promotional materials to health authorities as required
  • Build and develop Regulatory Labeling and Advertising/Promotion teams to support business needs

Requirements:

  • Bachelor's or graduate degree in a life science field (graduate degree preferred)
  • 8+ years’ experience in pharmaceutical or biotech industry in multiple phases of development. Experience in small and larger companies is preferred
  • Experience working with regulatory authorities worldwide
  • Thorough knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products, including labeling and advertising/promotional requirements
  • Strong organizational skills and ability to network and coordinate discussions across all levels of the company to reach resolution
  • Creative thinking ability; able to problem-solve, adapt and react to new information or changing priorities, and make difficult judgment calls within sphere of responsibility
  • Strong writing, project management and communication skills
  • Ability to travel within the US and internationally as needed (up to approximately 15%)

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

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.