Regulatory Affairs Manager

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Job ID SR0037085
Date posted 07/29/2019
Location: Zug, Switzerland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Regulatory Affairs Manager in our office in Pfäffikon.

OVERVIEW

• Leading the local regulatory product strategy working in collaboration with the Regional and Global Regulatory Leads to successfully deliver the product development and life cycle management plans in accordance with agreed business priorities. Also responsible for ensuring the compliance of registered products with local laws and requirements.


• Serving as the key liaison between the company and the local Health Authority. Building strong working relationships and conduct yourself with integrity with both internal and external stakeholders to protect and elevate Takeda’s reputation.


• Striving for a performance-based culture and deliver operational excellence working in a cross-functional environment within R&D and the Commercial business based on the Takeda values of Patient, Trust, Reputation and Business.

 Key Accountabilities

• For new MA registrations provide RA input for launch strategy aligned with commercial plan for timely submissions/approvals and management of national phases of Swiss Procedures. Maintain relevant knowledge of company’s pipeline in relevant Therapy Area Units


• Collaborate with Market Access team on the evidence generation and value proposition strategy including preparation of the Pricing and Reimbursement Dossier and follow up Renewal applications.


• Due diligence for locally in-licensed products from RA perspective including support for MA Transfers.


• MA lifecycle maintenance incl. renewals, variations (CMC and non-CMC), labeling updates, blue box requirements, PSUR/PBRERs and etc. Ensure national registrations are aligned with global dossier updates and take ownership of regulatory strategies for country specific National registrations. Pro-vide relevant local impact assessments for global dossier changes and initiate change requests for national licenses as per change control processes.


• Submissions of MAA and withdrawals of products after agreement with RA Switzerland Lead, Business and GM


• Manage compliance of labelling (and mock-ups) with CCDS (incl. updates for generics if originator product changes). Local translations of SmPC, labelling, patient information and distribution to internal and external stakeholders (incl. public lists, websites)


• Maintain Global and Local Regulatory databases to ensure accurate records of Regulatory activity and data archives as a key priority.


• Contribute to Regulatory Intelligence, stay up to date on local and EU laws and assess the impact on local business and products.


• Compliance with EU and local laws and Takeda internal processes including EU Food Supplements, Medical Devices, Cosmetics Directives.


• Build relationships with Health Authorities, understand their internal workings, maintain open communication channels and respond with urgency and accuracy to Health Authority requests. Active involvement and participation at Industry Associations


• Promote, encourage and demonstrate commitment to Takeda-ism


• Budget planning, managing RA contractors/CRO´s and oversight of outsourced RA activities in agreement with RA Switzerland Lead.

Key skills required

Critical Skills and Competencies

• Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies

• Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.


• Effectively embraces change and can flourish in a global structure, aligning people and processes to deliver excellence.


• Creates an open collaborative environment of continuous improvement within LOC stakeholders and Global functions


• Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking.


• Incumbents at this level are involved in a variety of diverse scope and complexity of projects which require strategic thinking and thorough and practical solutions.


• Highly organized


• Mature professional presence & credibility


• Ability to handle multiple tasks and work under pressure


• Desire to put people first and demonstrate the values of Takeda-ism

Experience and Education

• University degree in Pharmacy or other scientific studies


• Minimum of 3 years of experience in Regulatory Affairs


• Minimum 3 years of experience in pharmaceutical industry


• In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry


• Fluent in German and English, French/Italian is a plus

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. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. 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. Discover more at takedajobs.com.

What Takeda Can Offer You

To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Contributory Pension Scheme, Private Health Cover and Life Assurance.

Empowering Our People to Shine

Learn more at takedajobs.com

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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