Associate Director Regulatory Affairs CMC Onsite Hybrid
Associate Director Regulatory Affairs CMC Onsite Hybrid
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Salary Not Disclosed
1 Vacancy
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 the 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:
- Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions including new applications and amendments renewals annual reports supplements and variations and responds to regulatory information.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
- Develops strategies for CMC agency meetings manages preparation for agency meetings and manages content of premeeting submissions. Serves as the point of contact for the regulatory agency meetings.
- Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
- Represents CMC regulatory affairs on teams such as the product development Global Regulatory Product Teams and Operations brand teams for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation regulation and guidance provides analysis to the organization.
- Develops implements and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC.
- Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
- Trains develops and mentors individuals; may include formal supervisory responsibilities.
The leveling of this position is flexible. Applicants may be considered for the Senior Manager or Associate Director level based on qualifications. This role is hybrid onsite weekly in AbbVies Lake County IL office.
Qualifications :
- Required Education: Bachelors 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 with at least 3 years of demonstrated leadership
- Preferred Experience: 10 years pharmaceutical experience including 5plus years in regulatory affairs or 5plus years in Discovery R&D or Manufacturing.
- Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority.
- 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:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will 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 we 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
