Job Description
Job 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 accountable program(s).
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.
Education, Registration & Certification :
- B.S. or graduate degree in life sciences.
- Regulatory Affairs Certification preferred.
Experience :
- 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).
- Must have experience with early stage clinical development (pre-IND through Phase 2 POC), regulatory interactions and submissions.
Travel Requirements :
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 https : / / apellis.
com / careers / 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 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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