Senior Manager, Global Product Strategy (Regulatory Affairs)

About Pharming

Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture

Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Overview

Pharming is seeking to hire a Senior Manager, Global Product Strategy (Regulatory Affairs) to bring the development, implementation, and advisement of global regulatory strategies for Pharming products in development as well as marketed products. Our goal is to have this individual manage regulatory filings and submissions through all phases of development as well as post-approval across global markets. Successful execution will involve strategic regulatory oversight for designated projects ensuring that the latest global Health Authority requirements and standards are met.

Key Responsibilities

The Senior Manager, Global Product Strategy (Regulatory Affairs) will be responsible for a wide variety of matters in support of Pharming’s growth as we increase the number of both pipeline and marketed products.

Core functions include:

• Assisting in the development of Global Product regulatory strategies.

• Developing regulatory timelines aligned to company strategic goals including key regulatory milestones and activities.

• Acting as regulatory representative on cross-functional teams to provide guiance and recommendation on regulatory strategy.

• Acting as interface with Health Authorities.

• Identifying, assessing, and assisting in the mitigation of regulatory risks to the portfolio.

• Monitoring, collecting, analyzing, interpreting, and disseminating general Regulatory Affairs information to relevant stakeholders.

• Reviewing development data to ensure alignment with regulatory requirements.

• Contributing to submissions including investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), regulatory meeting documents, registration filings, and supplements/amendments thereof.

• Coordinating with Regulatory Operations team to ensure timely and accurate submissions to Health Authorities..

• Uses knowledge of regulatory requirements to both strategically and operationally development projects and market product regulatory issues to support corporate goals.

• This position is a remote role.

• Must have the ability to travel up to 15%.

  
  

Compensation & Benefits:

• Flexible hybrid work schedule to promote a health work-life balance.
• Competitive compensation package including annual target bonus.
• Long-Term Incentive Program
• 401(k) plan with company match
• Paid-Time Off Days
• 16 Company Holidays per year (typically last week of December up until New Year’s Day)

Other Benefits:

• Excellent Healthcare Plans including Medical, Dental and Vision.
• Flexible Spending Accounts for Medical and Dependent Care.
• Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.
• Accident, Hospital Indemnity and Critical Illness Plans.
• Pet Insurance Plan.
• On Premise Fitness Center.
• Health & Wellness Program.
• Choice of Mobile Phone for Work Use or Cell Phone Stipend.
• Pharming Academy – Continuing Learning & Development Program.

Additional Information

Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to HR-US@pharming.com.

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep submissions on file for six months.