Associate Director, RA CMC
BioSpace, Florham Park, NJ, United States
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience, and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first‑pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.
Responsibilities
Prepare CMC regulatory product strategies and manage regulatory submissions, including new applications, amendments, renewals, annual reports, supplements and variations, and respond to regulatory information.
Analyze and interpret information that impacts regulatory decisions. Seek expert advice and technical support as required for strategies and submissions.
Review and revise regulatory submissions to effectively present data and strategy to regulatory agencies.
Develop strategies for CMC agency meetings, manage preparation for agency meetings, and manage content of pre‑meeting submissions. Serve as the point of contact for the regulatory agency meetings.
Manage products and change control with an understanding of regulations and company policies and procedures. Analyze and approve manufacturing change requests.
Represent CMC regulatory affairs on teams such as product development, Global Regulatory Product Teams and Operations brand teams, negotiate with and influence team members to maximize chances for first‑pass approval of regulatory submissions.
Stay abreast of regulatory procedures and changes in regulatory climate. Analyze legislation, regulation and guidance, and provide analysis to the organization.
Develop, implement, and document policies and procedures within the regulatory affairs department. Lead initiatives internal to RA CMC.
Represent CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
Train, develop and mentor individuals; may include formal supervisory responsibilities.
Qualifications
Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
Preferred Education: Relevant advanced degree preferred. Certification a plus.
Required Experience: 8 years pharmaceutical experience with at least 3 years of demonstrated leadership.
Preferred Experience: 10 years pharmaceutical experience including 5‑plus years in regulatory affairs or 5‑plus years in Discovery, R&D, or Manufacturing.
Experience developing and implementing successful global regulatory strategies. Experience working with Health Authorities.
Experience working in a complex and matrix environment.
Strong oral and written communication skills.
Note: Higher education may compensate for years of experience.
Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law.
Compensation range described below is the range of possible base pay compensation that the company believes in good faith to pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and the company may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the company’s sole and absolute discretion until paid and may be modified at the company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
#J-18808-Ljbffr
Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first‑pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.
Responsibilities
Prepare CMC regulatory product strategies and manage regulatory submissions, including new applications, amendments, renewals, annual reports, supplements and variations, and respond to regulatory information.
Analyze and interpret information that impacts regulatory decisions. Seek expert advice and technical support as required for strategies and submissions.
Review and revise regulatory submissions to effectively present data and strategy to regulatory agencies.
Develop strategies for CMC agency meetings, manage preparation for agency meetings, and manage content of pre‑meeting submissions. Serve as the point of contact for the regulatory agency meetings.
Manage products and change control with an understanding of regulations and company policies and procedures. Analyze and approve manufacturing change requests.
Represent CMC regulatory affairs on teams such as product development, Global Regulatory Product Teams and Operations brand teams, negotiate with and influence team members to maximize chances for first‑pass approval of regulatory submissions.
Stay abreast of regulatory procedures and changes in regulatory climate. Analyze legislation, regulation and guidance, and provide analysis to the organization.
Develop, implement, and document policies and procedures within the regulatory affairs department. Lead initiatives internal to RA CMC.
Represent CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
Train, develop and mentor individuals; may include formal supervisory responsibilities.
Qualifications
Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
Preferred Education: Relevant advanced degree preferred. Certification a plus.
Required Experience: 8 years pharmaceutical experience with at least 3 years of demonstrated leadership.
Preferred Experience: 10 years pharmaceutical experience including 5‑plus years in regulatory affairs or 5‑plus years in Discovery, R&D, or Manufacturing.
Experience developing and implementing successful global regulatory strategies. Experience working with Health Authorities.
Experience working in a complex and matrix environment.
Strong oral and written communication skills.
Note: Higher education may compensate for years of experience.
Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law.
Compensation range described below is the range of possible base pay compensation that the company believes in good faith to pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and the company may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the company’s sole and absolute discretion until paid and may be modified at the company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
#J-18808-Ljbffr