VP, Head of US Regulatory Affairs and Pharmacovigilance

Job description

Your mission

VP, HEAD OF US REGULATORY AFFAIRS AND PHARMACOVIGILANCE

Pierre Fabre , the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.  

Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology. 

Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with " New Ways to Care ."  

Join Pierre Fabre Pharmaceuticals to make a real impact in people's lives. Your purposeful career begins here. 

SUMMARY:  

The Vice President of Regulatory Affairs and Pharmacovigilance is a key member of Pierre Fabre Pharmaceuticals Inc. leadership team.

He/She oversees all commercial regulatory affairs and vigilance activities for the Pierre Fabre Pharmaceuticals Inc. (PFP) portfolio.

He/she ensures that PFP has the needed resources and processes to comply with the applicable US regulations.  He/she is responsible for maintaining the right level of compliance according to the Corporate guidelines / SOPs; risk assessment and management at all levels of the subsidiary. Knowledge in Pharmacovigilance is required, in order to supervise Local Safety Officer(s) (in collaboration with Corporate Vigilance management). This role requires expert interpretation of requirements relating to the development and licensing of medicinal products in and for the US market and close collaboration with the Corporate Regulatory Affairs department (mainly Regulatory Development and Lifecycle Management teams).

This position will report to the CEO of Pierre Fabre Pharmaceuticals. 

ESSENTIAL FUNCTIONS:

Lead function and develop staffing plan (in house/ outsource) to meet requirements.

US Regulatory affairs Activities

·  Responsible for all regulatory commercial activities in the US
·  Responsible for Regulatory approval of promotional and non-promotional communication and training in accordance with US and international applicable regulations.
·  Responsible for Regulatory CMC, and close working relationship with Quality
·  Responsible for the Regulatory approval of Labeling
·  Evaluate and make recommendations for actions to abrogate regulatory risks
·  Ensure enterprise alignment in the development and maintenance of marketed products in US.
·  Establish and maintain relationships with Corporate  Regulatory Affairs colleagues (mainly Regulatory Development and Lifecycle Management teams).
·  Manage US regulatory vendors and budget
·  Represent interest in local trade associations and share information with internal stakeholders
·  Ensure that the appropriate resources and processes are set-up and in place in US to support Pierre Fabre Pharmaceuticals Inc. product life cycle management.
·  Responsible for Regulatory compliance oversight and Database management (RIM)

RV Team Management

·  Management of the local RV team: direct coordination and supervision of all local R/V activities, organizational improvements, people’s skills and expertise development.
·  Be involved in local RV job descriptions drafting, in yearly appraisals of local RV staff.
·  Ensuring cross-functional effectiveness and optimal networking at the local and corporate levels.
·  Ensure appropriate definition, coordination and follow-up of the local RV budget, in close partnership with the corporate.
·  With the Quality responsible person, develop and implement RV policies and procedures consistent with corporate policies and US requirements.
·  Ensure that all the key RV activities are performed and achieved according to Corporate guidelines and within the allotted time.
·  Ensure compliance in all operations & creation of RV SOPs as required.
·  Ensure regular reporting of activity through pre-defined metrics previously validated by the Corporate.
·  Manage on a daily basis any cross-functional activity related to RV and risk management.
·  Supervise and pilot closely local thirds parties with whom certain RV activities may be subcontracted.

Business Continuity

·  Ensures continuity of regulatory, vigilances activities at the local level, including the set-up of a system to cover out of business hours.

Regulatory Submission & stakeholder management

·  Work in close collaboration with the Global Head of Regulatory Development to ensure that all Pierre Fabre products are well developed bringing US market insights.
·  Provide strategic advice on integrated regulatory development plans in oncology and rare disease for US.
·  Educate company on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business.
·  Lead regulatory submissions to FDA.
·  Manages regulatory submissions and related supplements/amendments to the different FDA Divisions in collaboration with Corporate Regulatory Affairs.
·  Contribute to the review of regulatory submissions e.g. safety reports, promotional materials, and other relevant documents applicable to Pierre Fabre medicinal products marketed in the US, or under submission.
·  Interact directly with FDA and maintain excellent relationship with regulatory personnel.
·  Contribute to planning Agency interactions, and lead interactions with FDA (INDs, NDA/MAAs, DSURs, PIND/EOP2 meetings, etc.) in collaboration with the Corporate Regulatory Affairs teams, when relevant.

REQUIRED EDUCATION AND EXPERIENCE:

·  Advanced degree (PhD, PharmD, MD, MSc) with experience in regulatory affairs and GxP environment and knowledge in Pharmacovigilance.
·  Seasoned professional with at least 12 years of regulatory affairs experience in the biopharmaceutical industry.
·  Experience in a leadership role within the regulatory affairs function.
·  In-depth working knowledge of US regulations and regulatory requirements, and operational knowledge of IND/NDA/BLA submissions.
·  Strong track record of building an excellent relationship with FDA.
·  Experience on providing strategic advice on integrated regulatory development plans in oncology and rare disease; Experience in gene/cell therapies preferred.
·  Experience with development of biomarkers and IVD companion diagnostics devices would be a plus.
·  Experience in Safety (especially, operational PV) + qualification per training and over 2 (two) years’ experience in Pharmacovigilance.
·   Demonstrated success in defining and implementing SOP at a local level are mandatory.
·  Training or previous successful experience in risk management or equivalent is mandatory.

WORK ENVIRONMENT:

·  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Benefits of being a Pierre Fabre Employee  

Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees. 

Pierre Fabre    

Pierre Fabre has been recognized by Forbes as one of the " World's Best Employers " for the 3rd year running. 

https://www.pierre-fabre.com/en-us  

True to My Nature  

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. 

Who you are ?

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.