Apellis Pharmaceuticals
Senior Manager, Regulatory Intelligence
Apellis Pharmaceuticals, Waltham, Massachusetts, United States, 02254
Position Summary:
Reporting to the Head of Global Regulatory Operations, the Sr Manager, Regulatory Intelligence, will conduct regulatory intelligence gathering, consolidation, and communication activities to support global product teams. S/He will support external regulatory intelligence and advocacy activities as a member of trade and professional associations. The role will also be responsible for developing and maintaining knowledge management practices to maximize the impact of regulatory intelligence on product strategy for new drug development in early- and late-stage, and life-cycle management settings.
Key Responsibilities Include:
Support US & International Regulatory Affairs and other stakeholders in providing up-to-date intelligence, periodically and upon request.
Gather, analyze, assess, and communicate relevant global regulatory information and trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on Apellis’ products and regulatory business processes.
Adopt, implement and refine the Apellis regulatory intelligence process.
Collaborate with global regulatory functions, other Intelligence groups (e.g. Competitive Intelligence) and other departments to stay up to date with changes in the global regulatory environment.
Master the use of intelligence-gathering tools, databases, and internet-based information sources in the areas of Apellis therapeutics focus drug development.
Manage the internal communication of new health authority changes and consult with subject matter experts across the organization to establish and maintain their impact assessment programs.
Collaboratively develop and maintains knowledge management strategies related to regulatory intelligence, including using IT tools, facilitating working groups and educational forums, and creating team intelligence-sharing practices.
Anticipate changes in the external regulatory environment and identify educational- or policy-related opportunities to participate in public commenting, workshops, consortiums, working groups, or trade associations.
Oversee the utility and adoption of Apellis Regulatory Intelligence database and related tasks and processes.
Coordinate and report on trade association and consortium engagements across functions supporting new drug development
Provide strategic regulatory advice to RA colleagues on drug development projects and registration, and marketed products in preparation for HA meetings.
Develop and deliver training materials on new and emerging regulatory requirements for RA colleagues and other functions
Liaise between RA and vendors providing Regulatory Intelligence services to Apellis.
Education, Registration & Certification:
Bachelor's Degree required with preferred focus in the life sciences, medical science or pharmacy.
Post-graduate qualification or degree in Regulatory Affairs is advantageous.
Experience:
A minimum of 5 years of regulatory experience, preferably in regulatory strategy, or intelligence and health policy. Ophthalmology experience is desirable.
Skills, Knowledge & Abilities:
Regulatory experience in both drug development and post-marketing phases.
Experience in US, Canada, Australia, and Europe preferred. Other Global experience is desirable.
Deep understanding of health authority websites and public information sources, including regulations, guidance and policies governing drugs, biologics, and devices in all phases of development. Experience in combination products is desirable.
Outstanding written and oral communication skills.
Strong attention to detail and the ability to handle multiple tasks.
Ability to prioritize effectively thorough understanding of local compliance.
Working knowledge of Regulatory Intelligence Tools and staying up to date with Regulatory news regarding key competitors and the disease areas.
A good understanding of the commercial aspects of drug development.
Management and implementation of AI tools an advantage/desirable
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! 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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Reporting to the Head of Global Regulatory Operations, the Sr Manager, Regulatory Intelligence, will conduct regulatory intelligence gathering, consolidation, and communication activities to support global product teams. S/He will support external regulatory intelligence and advocacy activities as a member of trade and professional associations. The role will also be responsible for developing and maintaining knowledge management practices to maximize the impact of regulatory intelligence on product strategy for new drug development in early- and late-stage, and life-cycle management settings.
Key Responsibilities Include:
Support US & International Regulatory Affairs and other stakeholders in providing up-to-date intelligence, periodically and upon request.
Gather, analyze, assess, and communicate relevant global regulatory information and trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on Apellis’ products and regulatory business processes.
Adopt, implement and refine the Apellis regulatory intelligence process.
Collaborate with global regulatory functions, other Intelligence groups (e.g. Competitive Intelligence) and other departments to stay up to date with changes in the global regulatory environment.
Master the use of intelligence-gathering tools, databases, and internet-based information sources in the areas of Apellis therapeutics focus drug development.
Manage the internal communication of new health authority changes and consult with subject matter experts across the organization to establish and maintain their impact assessment programs.
Collaboratively develop and maintains knowledge management strategies related to regulatory intelligence, including using IT tools, facilitating working groups and educational forums, and creating team intelligence-sharing practices.
Anticipate changes in the external regulatory environment and identify educational- or policy-related opportunities to participate in public commenting, workshops, consortiums, working groups, or trade associations.
Oversee the utility and adoption of Apellis Regulatory Intelligence database and related tasks and processes.
Coordinate and report on trade association and consortium engagements across functions supporting new drug development
Provide strategic regulatory advice to RA colleagues on drug development projects and registration, and marketed products in preparation for HA meetings.
Develop and deliver training materials on new and emerging regulatory requirements for RA colleagues and other functions
Liaise between RA and vendors providing Regulatory Intelligence services to Apellis.
Education, Registration & Certification:
Bachelor's Degree required with preferred focus in the life sciences, medical science or pharmacy.
Post-graduate qualification or degree in Regulatory Affairs is advantageous.
Experience:
A minimum of 5 years of regulatory experience, preferably in regulatory strategy, or intelligence and health policy. Ophthalmology experience is desirable.
Skills, Knowledge & Abilities:
Regulatory experience in both drug development and post-marketing phases.
Experience in US, Canada, Australia, and Europe preferred. Other Global experience is desirable.
Deep understanding of health authority websites and public information sources, including regulations, guidance and policies governing drugs, biologics, and devices in all phases of development. Experience in combination products is desirable.
Outstanding written and oral communication skills.
Strong attention to detail and the ability to handle multiple tasks.
Ability to prioritize effectively thorough understanding of local compliance.
Working knowledge of Regulatory Intelligence Tools and staying up to date with Regulatory news regarding key competitors and the disease areas.
A good understanding of the commercial aspects of drug development.
Management and implementation of AI tools an advantage/desirable
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! 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.
#J-18808-Ljbffr