Director, Global Regulatory Strategy
Galderma Laboratories

Job Info

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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
Responsible for global regulatory strategies and global submission plans for QM1114: 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

• Lead QM1114 US BLA preparation, submission, and FDA review; be the FDA contact person - 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
• Member of QM 1114 GRT: responsible for parts of global regulatory strategy & submission plans for QM1114
• Support regulatory activities for any toxins not directly registered by Galderma where Galderma acts as distributor
• Coordinate regulatory CMC strategies with RA CMC
• Accountable for US regulatory strategy
• Identify and assess risks associated with product development and recommend strategies to mitigate these risks
• Ensure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed
• Manages dossier renewals for assigned products globally: activities include (but not limited to) regulatory strategy, dossier preparation with coordination of adequate Subject Matter Experts (such as 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 contribute to SOPs, forms, etc. to support regulatory development processes.
• Anticipates, contributes to improvements to processes and to ensure continued compliance with applicable regulations.
• Monitor internal and professional communications concerning relevant regulations (FDA, ICH, EMA, ...) in close collaboration with affiliates
• Prepare ad-hoc summaries and communication tools to inform relevant stakeholders / management

Management:

• Act as valuable member of the Global Regulatory Teams for Toxins / QM 1114
• Responsibility for ensuring collaboration with key internal stakeholders of GRA
• Participate to QM1114 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
• Minimum of 12 years experience in pharmaceutical/biotech Regulatory Affairs
• Minimum of 5 years as Global Regulatory Lead in Biological Product
• Successful proven experience of BLA submission and approval
• Proven experience of NCE/NBE development Regulatory Affairs
• Demonstrated experience in the preparation and submission of INDs, CTAs, NDA/BLAs, or MAAs
• Exceptions are possible if on balance the overall experience profile compensates any lack in an area
• Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (i.e. 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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