Vice President, Regulatory Affairs
This position will be responsible for Regulatory Affairs in the North America. This position will be the local agent for Sobi, will be responsible for the direct interactions with the FDA (both for Development projects, Life Cycle Management projects and marketed Sobi products). Responsible to manage and coordinate all Regulatory Affairs activities for Sobi Inc. North America (US and Canada), interact with regulatory authorities in collaboration with Global Regulatory Affairs, to advance the Company's drug development programs, as well as assist in the general operational management of the company such as review of promotional material and activities as part of the Sobi Inc. review committee.
Essential Responsibilities/Scope of the job:
Collaborate with Global Regulatory Affairs to establish the regulatory strategy for Sobi Inc. North America (US and Canada). Global Regulatory Affairs will set the strategy for the product globally, and the Head of North America Regulatory will provide input on the strategies that directly affect North America.
Stay abreast of regulations and other issues that affect corporate products and bring them to the attention of relevant staff, specifically those in Global Regulatory and Global Drug Safety.
Direct outside consultants and contractors as needed for local projects in scope of responsibility.
Interact with FDA and other regulatory agency staff in collaboration with Global partners to answer questions, plan meetings, obtain information, and otherwise facilitate regulatory interactions (apart from GMP inspections). Serve as the company's responsible contact for any necessary interactions with regulatory authorities.
Give input to and review all critical correspondence to and from regulatory authorities.
Manage local budgets for Regulatory Affairs.
Provide counsel, training, and interpretation of FDA's feedback, policies and guidelines to Sobi personnel and assist as a liaison between Sobi and the FDA.
Provide input to the design and assist in the interpretation of results for Clinical Studies required for FDA Approval.
Responsible for keeping Leadership Team informed of regulatory status of products and significant regulatory issues. Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones.
In collaboration with Global partners, effectively plan, organize, and conduct (or supervise) formal meetings with FDA. Interact with key personnel at FDA to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that influence Sobi's products and operations. Advise personnel in other departments regarding their applicability and impact.
Draft Cover letters, FDA forms and signing all applicable forms (electronically)
eCTD submissions will be handled by Global
Regular interactions with Corp. Regulatory Affairs. Responsible for constantly keeping Corp. Regulatory Affairs informed about all communications with the FDA and HC.
Review and submission of promotional material:
Review of labelling
Updating of SPL and local labeling on Daily Med and other national catalogues texts as applicable
Input to local product registers etc.
Develop local regulatory SOPs
Position Qualifications (knowledge, skills, abilities, education, experience):
Bachelor's degree required; advanced degree in science and/or business strongly preferred
Minimum of 10 years in regulatory affairs management positions within the pharmaceutical or biotechnology industry, both affiliate and global experience desired, with demonstrable accomplishments in regulatory affairs.
US/Canada product launch experience is required. Rare/Ultra Rare Disease product experience required; Rare/Ultra Rare Disease launch experience is strongly preferred.
Excellent written and oral communication skills; ability to communicate effectively, influence across multiple functions and project a professional image.
Excellent strategic thinking and analytical skills and an ability to connect insight with experience to shape a clear vision for the future despite a rapidly changing environment.
Excellent organizational skills, an ability to multi-task in an extremely fast-paced environment with changing priorities.
A good understanding of the processes involved in clinical research, process development, manufacturing, and marketing.
A good understanding of accelerated approval programs.
Experience with electronic regulatory submissions.
Good interpersonal skills and ability to lead and work with colleagues and with outside agencies professionally and tactfully.
Ability to effectively, collaboratively and respectfully lead in a matrix and within cross-functional teams.
Strong business acumen and an ability to work across geographic boundaries and cultures.
Ability to take initiative and prioritize tasks; good time-management, problem-prevention, and problem-solving skills.
Ability to independently exercise judgment in developing methods and criteria for determining appropriate action to obtain objectives.
Operational excellence, management skills, planning, prioritization, decision making, objective setting, meeting management and plan execution.
High integrity, proactive, adaptable and a strong work ethic.
Self-starter and team player who thrives in a dynamic and fast-paced environment.
Ability to maintain confidentiality of sensitive information.
Therapeutic Area knowledge within any of Immunology, Inflammatory diseases (rheumatology), oncology supportive care, and genetics
Familiarity with biologic drug development and commercialization.
Successful experience with FDA, Accelerated Approval, Breakthrough Therapy Designation and/or oncology BLA approval.
Proficient Microsoft office skills and adept at other technologies specific to performing regulatory affairs tasks.
The position will be based in Waltham, MA.
Chief Medical Officer .
For more information:
If you are interested in applying for this position, please submit your CV and cover letter through the apply button on the left-hand side.
Appointment of vacant positions at Sobi will take place with consideration of:
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.
The competences, experience, personal qualities, and motivators of the candidates;
The wish for Sobi to secure a well-functioning group with good team dynamics, able to be successful in an international, multi-cultural and cross-border business;
A wish for all Sobi employees to embrace and align with the company's values in their day-to-day operations.
Swedish Orphan Biovitrum AB