Head of US Regulatory Affairs & Quality
Location
Cambridge, MA | United States
Job description
Job Details
Title: Head of US Regulatory Affairs & Quality
Company: Ipsen Biopharmaceuticals Inc.
Job Description: The Head of Regulatory Affairs and Quality for US affiliate oversees all commercial regulatory affairs activities and quality oversight for the entire Ipsen portfolio marketed in US.
He/she is responsible to provide the relevant guidance for regulatory affairs activities for Ipsen product under development in US in close collaboration with the head of Global regulatory affairs US lead and the global regulatory affairs therapeutics area leads. He/she is responsible for maintaining the right level of GxP compliance across the US affiliates. He/she ensures that the US affiliates have the needed resources and processes to comply with the applicable US regulations.
Main responsibilities / job expectations The Head of Regulatory Affairs and Quality for US affiliate leads a team of 10 to 15 people with 2 main direct reports respectively covering regulatory affairs and quality activities.
- US Regulatory affairs Activities
- Responsible for all regulatory commercial activities in the US (marketed products)
- Ensure that the appropriate resources and processes are in place in US to support Ipsen product life cycle management.
- Provide leadership/guidance in the development of compliant sales training, advertising and detail literature
- Advise Medical Liaison and Medical Communications groups regarding regulatory issues and impacts of these activities
- Responsible for regulatory review and approval of promotional, advertising, and labeling items
- Evaluates and makes recommendations for actions to abrogate regulatory risks
- Manage and guide the US commercial regulatory team
- Ensure alignment between US commercial teams in the development and maintenance of marketed products in US.
- Establish and maintain relationships with global regulatory affairs colleagues.
- Manages US regulatory vendors and budget
- US Quality Activities
- Responsible for all GxP activities in the US for marketed and under development Ipsen products
- Ensure that the appropriate resources and processes are in place in US to support Ipsen product life cycle management in full compliance with applicable US regulations
- Manage and guide the US commercial regulatory team
- Act as key US quality representative within the US affiliate and the Global Quality Ipsen network
- Contribute to harmonization of GxP processes between global and affiliate teams
- Regulatory Submission & stakeholder management
- Contribute to planning and participation in interactions with FDA (INDs, NDA/MAAs, DSURs, PIND/EOP2 meetings, etc.) in collaboration with the global regulatory affairs teams
- Contribute to the review of clinical protocols and study reports, manufacturing process documentation, investigator brochures, safety reports, and other relevant documents applicable to Ipsen products marketed in US or under submission to.
- Support business development as needed (e.g., participate in due diligence efforts, interact with potential investors and partners).
- Work in close collaboration with the Head of Global US Regulatory affairs to ensure that all Ipsen products are well developed bringing US market insights
- Ethics & Compliance
- Ensure compliance with applicable regulatory reporting requirements, laws and regulations
- Ensure that adequate structures and controls are in place.
- Comply with Company guidelines and country/industry standards on ethics and compliance.
- Act as a role model displaying the 5 Ipsen Ways of Being
- Ensure that all activities are undertaken in accordance with all Ipsen SOPs, policies, directives and relevant national guidelines.
Knowledge, abilities & experience Education / Certifications:
- Degree in life sciences field.
- Ideally advanced degree (PhD, PharmD, MD, MSc) with experience in regulatory affairs and GxP environment
Experience:
- 8-10 years of experience in the biopharmaceutical industry in regulatory affairs or related field
- Experience in a leadership role within the regulatory affairs function
- In-depth knowledge of US and regulatory requirements, significant experience with FDA
- Prior experience in oncology, neurology and rare disease preferred
Languages:
- Fluent written and spoken English, French is a plus.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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