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SalaryPosition Summary:
The main responsibilities of this role are to participate in regulatory projects to achieve program deliverables and provide regulatory support to global clinical trial teams or other cross-functional teams. This individual will work closely with the Global Regulatory Lead for the assigned program(s) to ensure clear, consistent, and accurate regulatory guidance is provided to project teams and that regulatory deliverables are of consistent high quality and meet agency requirements and guidelines.
Key Responsibilities Include:
- Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications, amendments to INDs/CTAs).
- Work with the Global Regulatory Lead to achieve stakeholder alignment and meeting quality and timeline goals.
- Help define regional and country-specific regulatory requirements in major global markets and develop strategies to support clinical trial applications.
- Support ex-US submissions (led by CRO's) by providing guidance and core documents at study start.
- Track and respond to queries during the review and approval process.
- Monitor emerging trends regarding industry regulations and maintain awareness of evolving regulatory requirements or developments that pertain to our products.
- Communicate and provide guidance to teams on any regulatory changes to assure continued compliance.
- Conduct proactive gap analyses and regulatory risk assessments.
- Develop and recommend mitigation strategies to ensure that program activities are appropriately designed and implemented to meet global regulatory requirements.
Education, Registration & Certification:
- BS, MS, or doctoral degree (eg, PhD or PharmD) in a scientific field.
- RAC certification is desirable.
Experience:
- 7+ years of experience in Regulatory Affairs for drugs and/or biologics.
- Highly productive in a team environment working with an open mind and incorporating others’ input in planning and implementation.
- Flexible in approach to identify solutions that meet all regulatory requirements yet are least burdensome.
- Excellent oral and written communication.
- Functionally efficient in the high-paced environment typical of late stage companies.
- Willing to span the range of engagement from strategic thinking to hands-on drafting and submission of regulatory documents.
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 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.
