Associate Director, Regulatory Affairs

Position Summary :

Please read the following job description thoroughly to ensure you are the right fit for this role before applying.

The Associate 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.

Key Responsibilities Include :

• 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.

Education, Registration & Certification :

• B.S. or graduate degree in life sciences.
• Regulatory Affairs certification preferred.

Experience :

• At least 8 years of relevant experience, including experience as a regulatory lead and agency contact for development programs.
• Experience with post-marketing regulatory activities and late-stage global clinical development programs preferred.
• Experience with rare disease, immunology, and nephrology preferred.
• Regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development (big & small company experience preferred).

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.

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!

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 http : / / apellis.com 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.

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