CAREERS AT VYERA
Be a Part of the Vyera Vision
At Vyera, you can build a career that makes a valuable difference. We are proud to work with some of the most talented colleagues across the science, business and pharmaceutical industries. Together, we can vastly improve the lives of people who live with rare and serious diseases while driving a path forward in innovative medicinal advancements. Our team is seeking dedicated individuals to join our growing organization and contribute to finding solutions for some of our patients’ most critical challenges. Join us in implementing Vyera’s vision of patients living longer and healthier lives. Apply to one of our open positions today!
We Welcome Applications from All Qualified Candidates
We're looking for people who are passionate about identifying, creating and bringing to market therapies that can change the lives of underserved patients. We believe diversity is essential to creating a truly innovative and dynamic environment. To ensure that we support an atmosphere where innovative thinking can thrive, we look for applicants from a range of backgrounds and with a variety of work and life experiences.
If you’re interested in a career at Vyera, take a look at our current openings to find the best fit for your talents. Click any title to see a relevant job description and to submit your application for that position. If you have already submitted or saved an application, click My Account to retrieve it. For general applications, please send your resume to email@example.com.
Vyera Is an Equal Opportunity Employer
Vyera Pharmaceuticals, LLC is an Equal Opportunity employer. We are committed to the hiring, advancement and fair treatment of all individuals and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by federal, state, or local law. For more information about your rights as an applicant: EEO is the Law and EEO is the Law Supplement.
|Title:||Director, Regulatory Affairs (Submissions & Ad/Promo)|
|Number of Openings:||1|
SUMMARY OF POSITION
The Director, under the direction of the Head of R&D, will be responsible for regulatory strategy and operational leadership in the area of product and disease state communication for commercialized products and development programs. This individual will be responsible for ensuring that product and disease state communications meet the needs of the organization and are in compliance with applicable laws, regulations and guidelines in the U.S. In addition, this individual will be responsible for regulatory submissions to FDA, both post-approval and investigational. It is likely that the role will include submissions to foreign regulatory authorities, such as the European Medical Authority (EMA) and others, in the future. This is an exciting opportunity for a seasoned regulatory professional to contribute to the ongoing development of a growing regulatory function, with responsibility for the review of all advertising and promotional communications for the company’s products, as well as the ability to significantly contribute to new development programs directly.
MAJOR ACTIVITIES AND RESPONSIBILITIES
- Chairs the promotional review committee, providing input on processes and maintains all final approved materials.
- Reviews and approves product and disease state communications to support corporate goals and comply with applicable laws, regulations, and guidance in the U.S.
- Represents Regulatory Affairs on one or more internal multidisciplinary committees charged with the review and approval of product and disease state materials, as well as overseeing the submission of those materials to health authorities as needed.
- Works with the Research & Development team to develop submissions for Investigational New Drug applications and post-approval supplements.
- Provides regulatory guidance, and participates directly, in the preparation/creation of regulatory documents such as meeting materials, briefing documents, and expedited programs for serious conditions e.g. fast track designation etc.
- Collaborates cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal
- Creatively advises on the development of product and disease state communication materials across multiple functional areas, including Corporate Communications and other relevant areas
- Provides training to key stakeholders on laws and regulations related to drug advertising and promotion.
- Serves as the primary contact with the FDA Office of Prescription Drug Promotion (OPDP) for assigned products
- Monitors the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications, investigational drugs and post-approval changes which are essential to maintain compliance with applicable regulations
- Position will have primary approval responsibility for regulatory review of advertising and promotional materials for all commercialized products
- Position will be expected to know, or be trained immediately, on electronic submission capabilities for advertising materials and all regulatory submissions to INDs and NDAs for which the company is the application holder
- The successful candidate will have 5 – 7 years of experience directly related to the review and approval of advertising and promotional materials in a US pharmaceutical company.
- Demonstrated experience with regulatory submissions at the IND and NDA level
- Bachelor’s, or other professional degree, in a field with relevance to the pharmaceutical industry is preferred e.g. biology, chemistry, law etc.
- In depth knowledge of applicable regulations and guidelines to fulfill the requirements of the described position, primarily in the US
- Ability to work in a team environment to review and approve materials and meet corporate goals for submission
- Ability to work with appropriate computer systems required to develop and submit regulatory submissions. NOTE: this is not an electronic publishing position; those functions are conducted separately.
- Minimal travel required
Notice to Recruiters
Vyera's Human Resources Department manages the recruitment and employment process for the Company, and all candidates must be presented through this Department. If your agency wishes to establish a relationship with Vyera, you must work directly with the Human Resources Department. Contacting our hiring managers or employees directly is not appropriate. For more details, please email firstname.lastname@example.org.
For the protection of all parties involved, Vyera will only accept resumes from recruiters if an executed agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Vyera from recruiters do not constitute any type of relationship between the recruiter and Vyera and do not obligate the Company to pay fees should we hire from those resumes.