Lead, Regulatory Affairs Intelligence

4 maanden geleden

Leiden, Nederland Astellas Voltijd

About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

**The Opportunity**:
As a Lead of Regulatory Affairs Intelligence, you will be accountable for gathering and disseminating regulatory intelligence, delivering situational analyses, and making recommendations that encompass both the present regulatory landscape and the anticipated/desired future healthcare environment to bolster global and regional regulatory policy advocacy endeavors. You will be responsible for policy advocacy topics on global scale. Your position will be pivotal in engaging with internal departments across the organization and external stakeholders such as Trade Associations, Key Opinion Leaders (KoLs), and regulatory bodies.

**Hybrid working**:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

**In this role, you will**:

- Monitor and track upcoming regulatory legislations, providing analysis and targeted dissemination of regulatory intelligence to Regulatory Affairs and cross-functional stakeholders via various channels.
- Manage internal processes concerning draft/final guidelines, contributing to guideline consultancy processes in line with company strategy.
- Contribute to cross-functional initiatives, representing the Regulatory Intelligence and Policy function and/or Regulatory Affairs department and contribute to the development of Company positions and Action Plans for policy advocacy globally.
- Participate in industry working groups such as PhRMA, JPMA, EFPIA, RDPAC and BIO and participate and in Public-Private Partnerships or consortia such as IHI to represent Astellas
- Provide internal consultancy on regulatory information, interpretation of regulatory documents, and regulatory advice upon request.

**Essential Knowledge & Experience**:

- Significant experience within Regulatory Affairs, pharmaceutical industry, or related experience..
- Scientific knowledge and regulatory experience applicable to the role and solid basis in scientific approach, an ability to deal with technical information from a variety of disciplines.
- Experience in information searching and associated technology.
- Skilled networker and strong communication and collaboration skills
- High integrity to maintain confidential and proprietary information.

**Required qualification**:

- Health Science Diploma or equivalent.

**Additional information**:

- This is a permanent full-time position.
- Position is based in Netherlands, Belgium, Spain, Greece, or Portugal.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

**Job Types**: Full-time, Permanent

Work Location: In person

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