Descripción de la oferta
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma‑derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a R&D Global Regulatory Strategy Director like you.
Mission
The Director, R&D Global Regulatory Strategy serves as the strategic regulatory leader for assigned development biologic products on global project teams from preclinical stage to approval. This role is accountable for developing, owning, and implementing comprehensive worldwide regulatory strategies that support R&D objectives for new product development, and new indication expansions as well as for clinical aspects of Life Cycle Management Projects. Being the Global Regulatory Lead on global project teams, ensures that regulatory considerations are integrated into key decisions, development plans, and business strategies.
The Director, R&D Global Regulatory Strategy drives interactions with global health authorities to expedite approvals and interprets complex regulatory guidelines to ensure compliance and strategic advantage. Proactively assesses regulatory risks, opportunities, and pathways, anticipating challenges, and proposing innovative solutions to accelerate development.
The role also provides leadership and coordination to the Regulatory Teams, offering mentorship, direction, and driving collaboration as well as consistent execution of regulatory milestones and deliverables. Ensures alignment with senior stakeholders, and. fosters regulatory excellence and alignment between regulatory strategy, project goals, and broader organizational objectives.
What your responsibilities will be
As Global Regulatory Lead, develops and oversees worldwide regulatory strategies for projects and initiatives affecting new products or new indication development. Responsible for clinical aspects of LCM initiatives.
Leads the regulatory team assigned to the respective project to ensure alignment and integration of all aspects of development and seamless execution of strategy and submissions.
Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business.
Serves as a resource to other departments inside and outside of R&D on regulatory‑related product development issues.
Guides, directs, and leads staff, and develops department goals in accordance with business priorities. Responsible for training, reviews and development of department members.
Advises Senior Management on regulatory aspects of product development and/or lifecycle management.
Constantly monitors the evolving regulatory landscape of regulations, identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies and communicates in a manner that facilitates decision making.
Serves as Grifols regulatory liaison in collaborative projects with other companies as assigned.
Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
Manages department resources and budget to meet R&D goals.
Utilizes scientific training when interfacing with Senior Management of technical areas to guide the scope of experimentation and the selection of data needed to support regulatory submissions.
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
Requires Ph.D., Pharm. D., M.D. or equivalent.
8 years’ direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry.
Comprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and pharmaceutical industry.
Deep experience in clinical development, trial design statistical principles is essential.
Excellent oral and written communication skills.
Strong critical thinking and problem‑solving skills.
Excellent and demonstrated project management skills. Ability to negotiate and influence regulatory officials.
Ability to work cross‑functionally to effectively implement and oversee R&D regulatory programs.
Ability to evaluate complex issues, develop a plan, and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
Ability to work within a global team framework and multi‑cultural environment.
What we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.
Grifols is an equal opportunity employer.
Flexibility for U Program
Hybrid Model
Flexible schedule
Monday-Thursday 7‑10 to 16‑19h and Friday 8‑15h (with the same flexible start time).
Benefits package
Contract of Employment
Permanent position
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
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