Associate Director, Regulatory Strategy
Galderma Laboratories

Company Overview
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

Job Description
The Associate Director, Regulatory Affairs is responsible for global regulatory strategies and global submission plans for assigned chemical drugs, and any newly identified chemical drugs: builds and maintains a global regulatory strategy plan; assures relevant input is vetted and included in the regulatory strategy in order to deliver on the Target Product Profile, regional specific needs, regulatory environment, regulatory risks and mitigations, and global submission strategies. Follows (and executes necessary tasks) regulatory strategic leadership for development projects including health authority interactions (e.g. FDA but not only), regulatory submissions (e.g. IND, CTA, MAA, BLA, NDA) and other regulatory requirements in line with corporate objectives, timelines and budgets.

Job Responsibilities

• Manages the new registrations of chemical drugs globally: be the FDA contact person for US and coordinates preparation and submission globally - identifies and assess risks associated and proposes mitigations plans accordingly
• Prepares and coordinates documents to answer Health Authorities questions and submit to HA if applicable (US); close follow-up of the dossier review with affiliates; has an overview of all on-going procedures and communicates the status to management / identified stakeholders
• Global Regulatory Lead for assigned chemical drugs: responsible for global regulatory strategy & submission plans for assigned chemical drugs
• Supports regulatory activities for any chemical drugs not directly registered by Galderma where Galderma acts as distributor
• Coordinates regulatory CMC strategies with RA CMC
• Accountable for US regulatory strategy
• Identifies and assesses risks associated with product development and recommends strategies to mitigate these risks
• Ensures strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed
• Manages Life Cycle for assigned products globally: activities include (but not limited to) regulatory strategy, dossier preparation with coordination of adequate Subject Matter Experts (such as Pharmacovigilance and medical expert for addendum of clinical overview), coordination of answer documents in case of HA questions, follow-up of the approval
• Ensures that all regulatory documents are prepared and tracked in EDMS and that all regulatory activities are tracked in the regulatory affairs database
• Initiates, reviews and contributes to SOPs, forms, etc. to support regulatory development processes.
• Anticipates, contributes to improvements to processes and to ensure continued compliance with applicable regulations.
• Monitors internal and professional communications concerning relevant regulations (FDA, ICH, EMA, ...) in close collaboration with affiliates
• Prepares ad-hoc summaries and communication tools to inform relevant stakeholders / management

Management:

• Acts as Global Regulatory Lead of assigned chemical drugs
• Responsibility for ensuring collaboration with key internal stakeholders of GRA
• Participates to chemical drugs RA budget and team activities, as needed
• Accountable for management of outside vendors as needed

Minimum Requirements

• BSc in a Scientific discipline Required. MSc, or PhD in a Scientific discipline, or PharmD, Preferred.
• 10+ years experience in pharmaceutical/biotech Regulatory Affairs
• Experience in NCE/NBE development Regulatory Affairs
• Demonstrated experience in the preparation and submission of INDs, CTAs, NDA/BLAs, or MAAs
• Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, and EU)
• Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
• Experience interfacing with regulatory agencies and skill at implementing successful global regulatory strategies
• Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Excellent team interaction skills along with demonstrated ability to work on a cross-functional team
• Experience with international project management
• Focused on effective delivery of objectives, even when working with tight deadlines
• Ability to identify opportunities/major issues and to communicate impact
• Demonstrated ability to deal with rapid change

Other Important Information
Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

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