Regulatory Affairs Specialist
4 semanas atrás
Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Specialist, Regulatory Affairs Area, develops and executes regulatory strategies in alignment with Global and Affiliate Regulatory colleagues as appropriate. S/he represents Area on the Global Regulatory Product Teams (GRPTs) and leads Area Regulatory Product Teams (ARPTs) to identify and compile the information necessary to register and properly maintain regulatory applications to Health Authorities across the Area. This role also interfaces with partner functions (e.g., Commercial, Market Access, Quality Assurance) to ensure Regulatory strategies are aligned with business objectives.
Major Responsibilities:
- Provides strategic direction to support the development of compliant and competitive Regulatory programs;
- Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities;
- Effectively incorporates country-specific regulatory requirements, guidance, and other relevant regulatory intelligence into Regulatory submissions across the Area;
- Interacts with GRPTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updates on progress and/or issues that may impact the global program;
- Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all countries within the Area;
- Interacts with stakeholders across functions to ensure that Regulatory strategies are aligned with enterprise business objectives;
- Represents Area on process improvement initiatives of low- to medium-complexity; is able to represent the needs of Area and Affiliates as appropriate;
- Leads team meetings effectively; appropriately escalates and drives issues to resolution; demonstrates good negotiation skills, effective group facilitation skills, and ability to drive consensus among team members;
- Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential deliverables for a variety of audiences;
- Incorporates diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.
Qualifications
Required Education:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology etc.
Preferred Education:
- Advanced degree(s);
- English and Spanish are required. Portuguese fluency is preferred.
Required Experience:
- 5+ years’ related experience;
- Proven leadership skills and presence;
- Experience interfacing with government and health authorities;
- Experience working in a complex and matrix environment;
- Strong verbal and written communication skills;
- Ability to work with cross-functional teams;
- Ability to interact with different levels of stakeholders;
- Strong attention to detail and problem-solving skills;
- Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks;
- Keen awareness to cultural nuances; proven ability to work in a global environment;
- Ability to successfully interact with multi-divisional and multi-functional teams from across the globe.
Additional Information
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 AbbVie’s 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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