Galderma
Associate Director Regulatory Affairs CMC - Biologics
Galderma, Georgetown, Kentucky, United States, 40324
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Associate Director Regulatory Affairs CMC - Biologics Location: Boston, MA (Hybrid 3/days week in office) Description The Associate Director RA CMC -Biologics will report to the Head of Regulatory Affairs CMC. The Associate Director Regulatory Affairs CMC- Biologics will be responsible for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (focused on biologics and combination products). Develop CMC regulatory strategies and establish data requirements worldwide and prepares CMC sections for investigational and commercial products (CTIS, IND, MAA, NDA). Participates in new CMC activities from initial project plan to registration.
Key Responsibilities
Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information. Write/assemble CMC sections of regulatory submissions including clinical trial and variations/supplements as well as registration submission worldwide ensuring alignment with regulations, guidelines, policies and procedures. Manage answers to questions from the Authorities in a timely and effective manner to ensure early approval. Participate in interactions with Competent Authorities if needed. Develop and maintain project plans and schedules for CMC submissions. Evaluate proposed manufacturing changes for global impact and provide regulatory strategies that support change implementation. Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them. Provide guidance on ICH, FDA and EU CMC guidelines. Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams. Responsible for management of the service provider contracted to support a project, if appropriate. Ensure all CMC dossiers and relevant regulatory information are stored in the appropriate database according to company’s guideline.
Key Qualifications
BSc, MSc in a scientific discipline or Pharmacist required. 10+ years in CMC Regulatory Affairs for biologics. Global Experience Highly Preferred. Experience with biologics and/or combination products. Experience in interactions with Health Authorities (FDA/EMA). Focused on effective delivery of objectives, even when working with tight deadlines. Planning, organizing and time management skills. Problem solving and analytical skills. Ability to identify opportunities/major issues and to communicate impact. Demonstrated ability to deal with rapid change. Effective verbal and written communication skills in a cross functional environment and with external partners. Fluent in English.
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.
Next Steps
If your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager. The final step is a panel conversation with the extended team.
Our people make a difference
At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
Employer’s Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
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We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Associate Director Regulatory Affairs CMC - Biologics Location: Boston, MA (Hybrid 3/days week in office) Description The Associate Director RA CMC -Biologics will report to the Head of Regulatory Affairs CMC. The Associate Director Regulatory Affairs CMC- Biologics will be responsible for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (focused on biologics and combination products). Develop CMC regulatory strategies and establish data requirements worldwide and prepares CMC sections for investigational and commercial products (CTIS, IND, MAA, NDA). Participates in new CMC activities from initial project plan to registration.
Key Responsibilities
Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information. Write/assemble CMC sections of regulatory submissions including clinical trial and variations/supplements as well as registration submission worldwide ensuring alignment with regulations, guidelines, policies and procedures. Manage answers to questions from the Authorities in a timely and effective manner to ensure early approval. Participate in interactions with Competent Authorities if needed. Develop and maintain project plans and schedules for CMC submissions. Evaluate proposed manufacturing changes for global impact and provide regulatory strategies that support change implementation. Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them. Provide guidance on ICH, FDA and EU CMC guidelines. Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams. Responsible for management of the service provider contracted to support a project, if appropriate. Ensure all CMC dossiers and relevant regulatory information are stored in the appropriate database according to company’s guideline.
Key Qualifications
BSc, MSc in a scientific discipline or Pharmacist required. 10+ years in CMC Regulatory Affairs for biologics. Global Experience Highly Preferred. Experience with biologics and/or combination products. Experience in interactions with Health Authorities (FDA/EMA). Focused on effective delivery of objectives, even when working with tight deadlines. Planning, organizing and time management skills. Problem solving and analytical skills. Ability to identify opportunities/major issues and to communicate impact. Demonstrated ability to deal with rapid change. Effective verbal and written communication skills in a cross functional environment and with external partners. Fluent in English.
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.
Next Steps
If your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager. The final step is a panel conversation with the extended team.
Our people make a difference
At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
Employer’s Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
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