Associate Director, Regulatory Advertising - Waltham, United States - Apellis

Description

Job Description

Position Summary:

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, medical, 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 individual 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 programs and tactics (both promotional and non-promotional) that are compliant with regulations and company policies.

Key Responsibilities Include:

• 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.
• Undertake and coordinate regulatory training of Apellis personnel on regulatory issues pertaining to advertisement and promotion activities.
• Understands broad concepts within Regulatory Affairs and potential implications across the organization.
• Provides product development and label development strategies, as needed, to ensure promotional claims can be supported.
• Serves as primary liaison with OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for product/indication.

Education, Registration & Certification:

• Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)

Experience:

• At least 8 years' experience in pharmaceutical or biotech industry in multiple phases of development.
• Minimum of 4 years Regulatory Affairs experience in advertising and promotion.
• Experience working with OPDP.

Skills, Knowledge & Abilities:

• Previous experience guiding a commercial team through the FDA approval & launch process (either NME approval or new indication approval).
• Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion.
• Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plus.
• 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 assess areas of regulatory risk and 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.

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

Travel Requirements:

• Up to 20% travel expected.

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 to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit or follow us on Twitter and LinkedIn

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 pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.