Director, Regulatory Affairs -Rare Disease

Regulatory Affairs Waltham, Massachusetts


Description

Position Summary:

The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for the program(s) under his/her accountability.  Due to extraordinary growth, we have two positions in different therapeutic areas.

Responsibilities:

  • Ensure alignment of global regulatory strategies with Apellis corporate objectives. Collaborate with key internal stakeholders to ensure the global regulatory strategy is incorporated and implemented within the stakeholder deliverables.  Communicate to regulatory team, cross-functional teams, and senior leaders the immediate to long-range plans to carry out objectives established
  • Provide strategic global regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s), including clinical protocols, annual reports, clinical trial applications (CTA) / IND amendments, marketing applications, and post-approval change documents
  • Manage the content of global regulatory dossiers. Oversee and be accountable for regulatory agency submissions and approvals, with a quality focus to secure first-cycle approvals
  • Ensure compliance with global regulatory requirements. Work to resolve regional conflicts in global regulatory strategies and oversee critical deliverables to all territories
  • Represent the company at key regulatory agency meetings; moderate and lead discussions
  • Develop and maintain effective relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes
  • Proactively anticipate and mitigate regulatory risks
  • Research and analyze regulatory information; maintain current regulatory knowledge to keep abreast of regulatory procedures, changes, and trends. Provide relevant guidance and expertise to project/program teams
  • Demonstrate understanding of drug development and leadership behaviors consistent with level
  • Other duties as required

Qualifications:

  • BS. or graduate degree in life sciences
  • Regulatory Affairs Certification preferred
  • At least 8 years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development (with both big and small company experience)
  • Extensive experience with global regulatory processes, documents, and requirements (eg, INDs, clinical trial applications, marketing applications, meeting request procedures and materials)
  • Experience across multiple therapeutic areas, including rare diseases

Skills, Knowledge & Abilities:

  • Full functional knowledge of regulatory requirements (directives, regulations, and guidance) pertaining to the development and registration of drug products in multiple ICH regions
  • Strategic thinking ability, strong organization and planning skills, and ability to communicate effectively and efficiently to multiple audiences
  • Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (eg, orphan products, fast track, breakthrough therapies, PRIME, sakigake)
  • Proven leader with creative thinking ability; able to adapt and react to new information or changing priorities
  • Ability to set priorities, work independently, and deliver results in a timely manner with excellent problem-solving skills and ability to make difficult judgment calls within sphere of responsibility
  • Ability to travel within the US and internationally as needed (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 bio-pharmaceutical 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.