Role Description The Senior Manager, Regulatory and PV Delivery is responsible for providing franchise liaison between Ergomed Plc and client on a multiple projects’ program and actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. They also provide strategic regulatory guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff. - Assume leadership and functional representation for projects and/or deliverables of high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. - Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures. - Provide franchise liaison between Ergomed Plc and client on a multiple projects’ program. - Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance. - Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets. - Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery. - Provide training, coaching and mentoring to junior members of staff; may be required to line manage members of staff. - Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions. - Drive department/company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan). Qualifications - Minimum 5 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a leading/project management role. - Proven ability to successfully manage global projects. - Expert knowledge of ICH GCP and/or GVP and most relevant legislation/local requirements for territories of competency. Benefits - Training and career development opportunities internally. - Strong emphasis on personal and professional growth. - Friendly, supportive working environment. - Opportunity to work with colleagues based all over the world, with English as the company language.

• Establish and maintain high-quality scientific partnerships with Key Opinion Leaders (KOLs), senior clinicians, and decision-makers in oncology, rheumatology, and immunology. • Conduct unbiased, non-promotional scientific discussions on biosimilars including mechanism of action, extrapolation of indications, switching, interchangeability, real-world evidence, safety, efficacy, and immunogenicity. • Act as the primary medical point of contact for assigned regions and accounts. • Respond to unsolicited medical inquiries in a timely, accurate, and compliant manner. • Present and discuss clinical trial data, publications, and congress insights with external stakeholders. • Support medical education activities, advisory boards, and scientific meetings. • Generate and communicate medical insights to inform medical and brand strategy. • Support launch readiness, switch initiatives, and market access activities from a medical perspective. • Collaborate cross-functionally with Medical Affairs, Market Access, Commercial, and Pharmacovigilance teams. • Ensure compliance with local and global regulations, SOPs, and medical governance standards.

Title: Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC Location: North Chicago United States Employees work in a hybrid mode Full-time Salary Min: 124500 Salary Max: 236500 Workday Global Grade: 19 Compensation: USD 124,500 - USD 236,500 - yearly Job Description: 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. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. 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. 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 - Responds to global regulatory information requests. - Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. - 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. Participates in initiatives internal to RA CMC. Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company. - This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters. Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required 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. 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 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 thisposting 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 long-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 employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Role Description The Licensing Manager owns the growth and management of select licensing partnerships for the Kenmore and DieHard brands. The Manager is responsible for actively prospecting and closing new licensing deals while managing and growing an existing portfolio of licensee partners. The role requires strong commercial instincts, a proven ability to close business, and the operational discipline to manage a high-volume program of licensee relationships simultaneously. Reporting to the Senior Director of Licensing, the Licensing Manager will own an annual new business target, build and manage a prospective licensee pipeline, and independently close deals exercising discretion and judgment on contract terms and deal structures from initial outreach through signed agreement. At the same time, the Manager will serve as the primary relationship owner for assigned licensees - conducting business reviews, driving performance, ensuring compliance, and identifying growth opportunities. The Manager will also oversee product approvals and ensure brand integrity is maintained across all licensed products in the marketplace. Qualifications - Bachelors Degree - 5-10 years of related experience - Up to 25% travel - 18 years of age or older Requirements - Excellent communication, negotiation, and presentation skills; comfortable engaging at C-suite level - Solid understanding of licensing agreement structures, royalty mechanics, and minimum guarantee management - Highly organized with strong project management skills; able to manage multiple deals and partners simultaneously - Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) Job Duties/Responsibilities - Owns and delivers against an annual new business target; proactively identifies, qualifies, and independently closes new licensing deals across all product categories relevant to Kenmore and DieHard - Builds and maintains a robust new business pipeline through outbound prospecting, cold outreach, industry events, and trade shows including Licensing Expo; develops compelling brand presentations and licensing pitch decks to attract new partners - Serves as the primary relationship owner for an assigned portfolio of licensees across Kenmore and DieHard; conducts regular business reviews, drives performance, and proactively identifies growth opportunities including category expansions and territory extensions - Maintains and updates Licensee Product and Retail Road Maps; manages efficient execution of licensing agreements, amendments, and renewals in partnership with Legal - Manages the company's royalty reporting and product approval platform; ensures all licensees are onboarded, data is accurate, royalty submissions are timely, and product approval workflows are executed within established SLAs - Monitors royalty submissions for accuracy; follows up on delinquent reports and flags discrepancies to Finance and senior leadership - Ensures all licensed products, packaging, and marketing materials comply with brand guidelines for Kenmore and DieHard; coordinates with Design and Marketing teams to maintain and distribute current brand style guides - Negotiates, finalizes, and executes licensing agreements within established deal parameters, including approval of contract terms and deal structures; collaborates with Legal on complex or precedent-setting provisions and manages trademark use requests and NDA execution with prospective partners - Initiates deal strategy, category prioritization, and territory planning for North America and global markets; determines when to escalate non-standard deal structures or strategic exceptions to the Senior Director of Licensing - Reports on pipeline activity, deal progression, royalty performance, and closed business to senior leadership on a regular cadence - Represents the Brands business at key industry events and trade shows to generate new leads and strengthen existing licensee relationships - Identifies opportunities for external program visibility including industry awards and licensed product media coverage; promotes the licensing program internally through stakeholder presentations and company events