Sr. Manager Regulatory Affairs, Marketed Products - EUCAN
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
What makes a successful member of our team?
We take action and make decisions by focusing on our four priorities in this order:
Putting the patient
at the center
Life at Takeda
To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.
Procurement Lead, Northern Europe
“Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
Regional Head, Europe, Vaccines
“Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Sr. Manager Regulatory Affairs, Marketed Products - EUCANApply Now
Senior Manager, EUCAN (Europe & Canada) Regulatory Affairs
Strategy Lead, Marketed Products
- Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements, in order to enable patient access to meaningful medicines. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
- Provides regulatory expertise and strategic focus for assigned development projects
- As Regional Lead, may be called upon to act as deputy to the Global Regulatory lead, attending internal leadership team meetings, as appropriate
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements
- For centralized products may be primary EMA contact for project(s)/products of responsibility. Informs the business. May manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).
- Leads the regulatory working team for own region and may represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan
- Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe). Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
- Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility. Authors and reviews regional regulatory strategies as well as executes day-to-day activities for
- May include some oversight of vendor activities.
- May lead and manage meetings in own region (e.g. EMA for Europe) and has awareness of relevant regulatory agency meetings scheduled with other regions (such as FDA) or Local Takeda affiliates for project(s)/product(s) of responsibility.
- May be called upon to support in due diligence for licensing opportunities,
- Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or Region in these areas.
- Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS degree or equivalent in science; advanced degree preferred
- Experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
- Sound working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the EU). A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
- Proven regulatory submissions capability in a region basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Able to demonstrate skill(s) in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization.
- Generally strong in working well with others and within global teams.
- Able to bring working teams together for common objectives.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
Job ID R0013508