Director, Regulatory Affairs-CMC

Regulatory Affairs San Francisco, California


Description

Position Summary:

The Director, Regulatory Affairs CMC will drive strategies and lead processes for all CMC Regulatory activities for Apellis’ products. The Director will be responsible for implementing a global CMC Regulatory strategy and will lead all CMC regulatory activities and the coordination on all aspects of CMC Regulatory submissions. The Director will be expected to define CMC regulatory submission strategies; plan, review, construct and direct the filing of all CMC submissions globally such as INDs, CTAs, IMPDs as well as marketing applications in US, EU, Asia Pacific, Latin America etc., and support review and approval by regulatory agencies.

Key Responsibilities Include:

  • Formulate, lead and drive CMC regulatory strategy for development products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
  • Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams in a timely manner. Manage high level risk by making complex judgements, developing innovative solutions and applying comprehensive cross-functional and industry understanding in resolving CMC challenges.
  • Identify as early as possible, the required documentation and any content, quality and/or timeline issues. Negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Define, plan and manage preparation of CMC submissions and submission content for all global applications and support their approval by regulatory authorities. Ensure that CMC-related applications and/or sections (including INDs/CTAs, marketing applications, and other submissions) are complete, well written, and meet all relevant requirements. Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities within the required timelines.
  • Effect timely and appropriate regulatory management of amendments and post-approval CMC changes to Apellis products and evaluate regulatory impact on global marketing applications. Provide operational, tactical and strategic regulatory CMC expertise and direction to all project teams in a collaborative environment.
  • Prepare for and lead interactions with global regulatory authorities on CMC issues.
  • Collaborate closely with colleagues in Regulatory Affairs, Quality Assurance, Technical Operations, and other functions. Communicate effectively to set clear direction for the team and advise and influence others across all locations.
  • Maintain awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics. Ensure that global CMC regulations and guidance are applied to required processes, and lead development of new processes as required.
  • Other duties as required.

Education, Registration & Certification:

  • Doctorate, Master's, or Bachelor's degree in a life science field (Biology, Chemistry, or Pharmaceutical sciences).

Skills, Knowledge & Abilities:

  • A minimum of 10 years’ experience in regulatory within biotech and pharmaceutical industries and 6+ years of relevant regulatory CMC experience, including direct involvement in investigational applications, global marketing applications, and post-approval management activities
  • Extensive knowledge of all aspects of product development process related to CMC manufacturing, packaging and labeling.
  • Experience with multiple product types (eg, small and larger molecules experience a plus).
  • Strategic thinking ability, strong organization and planning skills, and ability to communicate effectively and efficiently to multiple audiences.
  • 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.

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.
  • Some travel will be required within the US and internationally as needed (approximately 10-15%).

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.