Deputy Responsible Pharmacist / Associate Director Regulatory Affairs, France

Job Description Summary:

Deputy Responsible Pharmacist / Associate Director Regulatory Affairs, France

The Deputy Responsible Pharmacist (DRP)/ Associate Director Regulatory Affairs, France will join the French affiliate of PTC Therapeutics based in Paris.

The Deputy Responsible Pharmacist / Associate Director Regulatory Affairs reports into the Responsible Pharmacist who reports into the VP International Regulatory Affairs.

The Deputy Responsible Pharmacist / Associate Director Regulatory Affairs will work with the Responsible Pharmacist (RP) to maintain the Pharmaceutical Establishment License and work with all cross-functional counterpart in the French affiliate to support local activities.

The Deputy Responsible Pharmacist / Associate Director Regulatory Affairs deals with complex and sensitive issues with a sense of urgency while communicating to others internally and externally. The incumbent has autonomy to conduct various projects to support both PTC commercial and development products, including the launch of a new product for PKU.

The incumbent ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

Job Description:

Responsibilities of the role include: 

• Acts as Responsible Pharmacist when the Responsible Pharmacist is offsite
• Maintains the quality system (SOP maintenance, handling of deviations, CAPAs, change control and risk management)
• Oversees PTC product supply (distribution and storage requirements, transportation, batch recall) in collaboration with the Responsible Pharmacist
• Collaborates in the pharmaceutical establishment quality review
• Manages technical agreements/contracts in collaboration with the Responsible Pharmacist
• Manages of audits/inspections in collaboration with the Responsible Pharmacist
• Reviews/approves media/promotional material and communication
• Reviews and approves packaging materials
• Reviews, approves and submits educational materials
• Provides regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for such programs (e.g. compassionate access and early access in France)
• Oversees Pharmacovigilance activities
• Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations, as applicable
• Serves as a liaison to regulatory Health Authorities in France and potentially other national authorities in the region and provides guidance and advice on regulatory and policy developments to PTC’s global regulatory team and other key stakeholders
• Actively maintains knowledge of French regulatory requirements (e.g. new regulations, laws, etc.) and shares key insights with the business and global team
• Ensures that drug products distributed with the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives.
• Ensures compliance to anti-gift law and transparency law

Requirements for the role include: 

• Pharmacist / Doctor with experience of 3 to 5 years as Deputy Responsible Pharmacist, experience of 5 to 8 years in Regulatory Affairs in the field of rare diseases (CTA application and Registration).
• In-depth knowledge of relevant, regional regulatory guidelines and requirements for application in an emerging regulatory landscape.
• Knowledge in handling quality records (Deviations, CAPAs, Change Control).
• Demonstrated success gaining regional regulatory approval and in providing regulatory support for post-marketing and life cycle management activities such as variations, renewals and labelling. Experience in US registration would be a plus.
• Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Fluent in English (verbal and written).
• Travel requirements. Occasional national, regional, and international travel which will vary according to ongoing initiatives.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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