Regulatory Affairs Manager Rare Diseases

**Department**: RDU Regulatory Affairs

**Job Type**: Direct Employee

**Team**: R&D, Pharmacovigilance & Regulatory Affairs

**Contract Type**: Permanent

**Location**:
Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

The unit is headquartered in Boston, Massachusetts, and has an initial focus on research and product development for lysosomal storage diseases, rare hematology and ophthalmology disorders. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.

Purpose

The International Regulatory Affairs Manager is responsible for managing activities within GRDRA that pertain to the development, submission, approval and maintenance of products in the Global Rare Disease Business Unit’s portfolio in identified international markets, specifically in the MENA region.

Main Responsibilities
- In collaboration with consultants, partners and affiliates, plans, coordinates, and manages regulatory submissions to international agencies throughout the life-cycle of Global Rare Disease products.
- Provides advice and guidance regarding international regulatory requirements on assigned multidisciplinary project teams driving the development and geographical expansion of Global Rare Disease products.
- Contributes to the preparation and/or review of submissions to international markets to ensure high quality.
- Contributes to the creation of regulatory strategies aimed at successful approval of Chiesi’s Global Rare Disease products in identified international markets in the shortest possible time.
- Manages, coaches and empowers team members to ensure targets and timelines are met and to maximize their professional potential.
- Interacts with staff of external organizations and regulatory agencies, as applicable, to negotiate strategies and actions associated with regulatory submissions.
- Contributes to the development of processes and the preparation of Standard Operating Documents for Global Rare Disease RA.
- Provides regulatory guidance to colleagues from other functional areas.
- Performs all other duties as assigned.

Experience Required

At least 8 years’ experience in Regulatory Affairs spanning multiple international jurisdictions; relevant experience in a leadership/project management or influencing role, preferably in drug development and product life cycle management in innovative pharma or equivalent, is highly preferred.

Education

Degree (preferably MSc, equivalent, or higher qualification) in an appropriate field, e.g., Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine.

Diploma from an RA program or Regulatory Affairs Certification would be an asset.

Languages

Fluent English

Technical Skills
- In-depth knowledge of multi-regional regulatory requirements (e.g. Canada, Australia, Rest of the World jurisdictions, etc.).
- Proven problem-solving capabilities, ability to evaluate risks and understand the impact of regulatory activities on business outcomes.
- Ability to formulate, propose and negotiate strategies and operational plans in multidisciplinary forums.

Soft Skills
Attention to details
Problem solving
Team working
Communication skills
Decision making
Planning and organizational skills
Strategic thinking

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most val