Regulatory Affairs Manager (d/f/m) – temporary for 1 year | Kundl, Austria

Sandoz Österreich; Kundl; Vor Ort; EUR 65 000 - 76 000; Vollzeit

Zusammenfassung

A leading biopharmaceutical company in Kundl, Austria, seeks a Regulatory Affairs Manager to support biosimilar and biotech projects, ensuring timely regulatory submissions. Ideal candidates have a relevant advanced degree and experience in biotech Regulatory Affairs. Responsibilities include implementing regulatory strategies and preparing documentation for global submissions. This role offers a competitive salary and flexible working arrangements.

Leistungen

Attractive salary with incentive program

Modern company pension scheme

Flexible working hours / home-office

14 weeks of paid parental leave

Subsidized meals

Wellbeing & mental health offers

Qualifikationen

• Minimum 2-3 years’ work experience in biotech Regulatory Affairs.
• Good understanding of regulatory requirements for filings worldwide.
• Critical evaluation of emerging requirements for new drugs.

Aufgaben

• Implements regulatory strategy for assigned regions.
• Provides input into global regulatory strategy.
• Facilitates timely submission of dossiers.

Kenntnisse

Excellent data processing skills

Strong ability to interpret scientific information

Strong analytical problem-solving skills

Ability to construct persuasive documents

Fluent English (oral and written)

Ausbildung

Advanced degree in life sciences/healthcare (PharmD/PhD)

Tools

MS Office

Jobbeschreibung

Overview

Regulatory Affairs Manager (d/f/m) – temporary for 1 year | Kundl, Austria

Join to apply for the Regulatory Affairs Manager role at Sandoz Österreich. This role supports biosimilar and biotech projects and prepares high quality regulatory documentation for complex global regulatory submissions worldwide in a timely manner. The RA Manager is responsible for executing and implementing the regulatory strategy besides providing regulatory and strategic support of assigned biosimilar/biotech projects and tasks through development, registration and approval/post approval. This is a temporary position limited to one year.

Responsibilities

• Implements regulatory strategy and manages operational activities for assigned regions.
• Provides input into global regulatory strategy and contributes to Regulatory Strategy Plans and Seed Document, including identification of gaps or risks in global strategic plan for assigned regions.
• Partners with regions to align on regulatory strategy in order to fulfill business objectives and implements strategy across assigned regions.
• Determines requirements and sets objectives for Health Authority (HA) interactions with RBio GPT representative and/or Head Regulatory Biosimilar Development.
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents; develops and implements plans for timely response to HA requests and coordinates responses.
• Drives coordination, planning, and submission of dossiers in assigned regions worldwide; develops and implements plans to avoid/minimize clock stops during submission review.
• Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs); provides input on Risk Management Plans.
• Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the RBio GPT representative and/or Head Regulatory Biosimilar Development.

Essential Requirements

• An advanced degree in life sciences/healthcare (PharmD/PhD) or relevant industry experience
• Mininum 2-3 years’ work experience in biotech Regulatory Affairs
• Excellent data processing skills (incl. MS Office)
• Strong ability to interpret scientific and commercial information
• Strong analytical problem-solving skills
• Strong ability to construct persuasive scientific/regulatory documents
• Good understanding of regulatory requirements for filings worldwide and critical evaluation of emerging requirements, guidelines for new drugs and product life cycle maintenance
• Fluent English required (oral and written)

You’ll Receive

• Attractive salary with incentive program
• Modern company pension scheme
• Flexible working hours / home-office depending on the position
• 14 weeks of paid parental leave
• Additional days off (bridge-days)
• Subsidized meals in our canteen
• Sustainable mobility in the form of company transportation, shift buses and car sharing
• Company Kindergarten and summer camps for children
• Wellbeing & mental health offers
• Learning and development options for your personal and professional growth
• Worldwide career opportunities

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 65.605,54/year (on a full-time basis). In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve. If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at [e-mail].

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Contact

For inquiries, please refer to the contact above or the application process details.