strategist, global regulatory affairs cmc, pdt bu (f/m/x).

• Defining, coordinating and implementing global CMC regulatory strategies for product-specific development and life-cycle activities
• Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets.
• The role liaises directly with the US FDA and with local regulatory teams for discussons with international health authorities and agencies for CMC-related matters. Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval.
• Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives.
• Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals.
• Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.
• Identifies and recommends the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations.
• Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant stakeholders or functions in line with Takeda's operating model with the purpose to obtain, maintain and extend Takeda PDT BU product registrations in global markets. Provides proactive guidance and regulatory strategies to support PDT product teams.
• Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs.
• In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams.
• In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully document in the respective quality management system.
• Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.
• Maintains an ongoing and interactive relationship with regional and local regulatory teamsto assure that all aspects of the company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
• Creates high quality, compliant regulatory CMC documents within defined timelines as per Takeda's PDT BU objectives.
• Participates in discussions and negotiations with regulatory authorities, agents, business partners, proactively and as required.
• Assists in the conduct of regulatory agency inspections and compliance audits.

Your Qualifications

• Bachelor's degree in a scientific discipline (advanced degree preferred)
• 5+ years of biotechnology/pharmaceutical industry experience
• 3+ years of regulatory CMC experience (biologics or plasma preferred)
• Demonstrated ability to collaborate within teams and with key cross functional areas
• Demonstrated experience in authoring and managing components of regulatory submissions
• Good knowledge of global regulatory CMC requirements and experience with interactions/negotiations with global health authorities
• Strong oral and written communication and negotiation skills
• Highest level of compliance integrity and business adaptability

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

• The role requires an extensive experience in global pharmaceutical/biotechnological drug development and proven knowledge of the global regulatory CMC environment.
• Demonstrated experience in authoring and managing components of regulatory submissions

• Good knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with FDA. Ablility to support regional and local regulatory affairs teams for interactions with regional or local health authorities (e.g., EMA, PEI, AGES, PMDA, Health Canada, etc.).
• Demonstrated ability to devleop and implement global CMC regulatory strategies, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.
• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve development and commercial goals.
• Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, drug development and/or expedited regulatory pathways.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Demonstrates strategic enterprise thinking finding innovative ways to serve patients, and build trust, reputation and business
• Creates the environment that inspires and enables people to move the organization forward
• Focuses on the few priorities and delivers superior results
• Elevates the capabilities of the organization for now and the future
• Ability to motivate, mentor and manage a diverse team in a matrix environment.
• Provides strategic vision, leadership, management and oversight in defining proactive global CMC regulatory strategies to support and accelerate the PDT BU product portfolio.
• Global perspective with a demonstrated ability to work across functions, regions, and cultures.
• Ability to identify potential challenges and opportunities, and make respective recommendations and decisions.
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the organization.
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviours for the organization.
• Invests in helping others learn and succeed.
• Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

• Accountable for acting decisively and exercise sound judgment in making decisions with limited information.
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.
• Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities.
• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution.
• Develops executable plans and meets deadlines.
• Builds a culture of data driven decisions.
• Ability to challenge self and others to overcome regulatory barriers and deliver high quality solutions to the business.
• Ability to negotiate and influence without authority in a matrix environment.
• Crisp decision-making following appropriate consultation, even in times of ambiguity.

Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)

• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU.
• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions.
• Strong communicator, able to persuasively convey ideas verbally and in writing.
• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk-taking)

• Continuously challenging the status quo and bringing forward innovative solutions.
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

• Delivers solutions to abstract problems across functional areas of the business.
• Identifies and solves fundamental issues for major functional areas through assessment of in-tangible variables.
• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity.
• Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy.

Resilient and comfortable working through large scale global change management.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately.

The minimum salary for this position is € 6.478,57 gross per month (full time 38 h/week, All-In, collective wage agreement for the chemical industry), due to your professional experience and your qualifications an increased payment is intended. The contract will be limited for 1 1/2 year, an extension of the contract is possible.

If you are interested in finding out more about this position, please send your informative application via www.randstad.at.

We draw your attention to the fact that your application documents in their entirety, including all personal data contained therein, will be forwarded to Takeda for the purpose of carrying out the application procedure and the pre-selection.

Facts

• AUT - Vienna
• Employee
• Fixed Term (Fixed Term)
• All-In