Job FunctionsDeveloping and implementing global regulatory affairs planDesigning and implementing launch strategies and tacticsPlanning life cycle management of products globallyContributing to public sector reforms, advising on regulatory frameworks, and advancing product development plans
Job RequirementsCollaborating with Clinical Development, Pharmacovigilance, Biometrics, Core Team Members, Product Management, Commercial, Medical Affairs, and Leadership teamContributing to regulatory due diligence assessments of product opportunitiesMonitoring competitive environment for threats to and opportunities for productsContributing to review of strategic regulatory submissionsAdvising staff in preparation for regulatory authority meetingsProviding input to submission strategy and other critical regulatory documentsCollaborating with Government Affairs and Commercial to advance important regulatory and other government policies that impact product development and commercialization
SkillsExpertise in product development, policy analysis, stakeholder engagement, and synthesizing complex information into actionable recommendationsProven ability to partner effectively with multiple functionsStrong interpersonal skillsOutstanding leadership and project management skillsRigorous scientific intellectUnderstanding of the business aspects of drug developmentHighly motivated individual who thrives on being challenged and working in highly collaborative environmentsHigh level of energy, focus, and passion for developing important new medicines for devastating diseasesAbility to work remotelyExemplary behavior, leadership, ethics, and transparency within the company, with Health Authorities and other external stakeholders
Description
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.
We offer a dynamic workplace for employees to grow and develop their skills.Ascendis Pharma is looking to hire an experienced Director, Regulatory Strategy and Policy Advisor to join our team. This is an exciting opportunity to join a rapidly growing innovative company.The Director, Global Regulatory Strategy and Policy Advisor, will be at the forefront of our strategic and policy initiatives, working closely with senior leadership and key cross-functional stakeholders to analyze, develop, and implement strategies and drive policies that align with our mission and objectives.
In this role, you will be responsible for providing advice on global regulatory strategies to product development teams and driving key policy initiatives. This position demands a high level of expertise in product development, policy analysis, stakeholder engagement, and the ability to synthesize complex information into actionable recommendations. Whether you are contributing to public sector reforms, advising on regulatory frameworks, or advising on strategies to advance our product development plans, your insights and guidance will play a pivotal role in shaping outcomes that matter.The Director, Global Regulatory Strategy and Policy Advisor, will work closely with the executive team to formulate strategies, enhance performance, implement relevant policies, and provide key insights that enable the organization to operate collaboratively and proactively. This role involves engaging closely with internal peers and external stakeholders such as regulatory and other government agencies. The ideal candidate will have a proven ability to partner effectively with multiple functions, including Clinical Development, Research, Product Development, Medical Affairs, Government Affairs, Commercial and Quality. Strong interpersonal skills are essential, as this individual will serve as a trusted voice within the company. The candidate must demonstrate outstanding leadership and project management skills, rigorous scientific intellect, and an understanding of the business aspects of drug development.At a personal level, the company is seeking a highly motivated individual who thrives on being challenged and working in highly collaborative environments to contribute to their cutting-edge science.
This highly visible position requires a high level of energy, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases. This candidate will report to the Chief Regulatory & Safety Officer and may work remotely.
Requirements
Key Responsibilities
- Collaborate with and advise Clinical Development, Pharmacovigilance, Biometrics, Core Team Members, Product Management, Commercial, Medical Affairs, and Leadership team to develop and implement the Global Regulatory Affairs plan across products, design and implement launch strategies and tactics, and plan the life cycle management of our products globally.
- Collaborate with Government Affairs and Commercial to advance important regulatory and other government policies that impact product development and commercialization.
- Contribute to regulatory due diligence assessments of product opportunities
- Monitor the competitive environment to maintain awareness of threats to and opportunities for our products
- Contribute to the review of strategic regulatory submissions
- Advise staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents.
- Provide input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
- Actively collaborate with Senior Management and cross-functional partners to provide portfolio or therapeutic level regulatory insight and broader drug development expertise.
- Actively be up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment.
- Support regulatory intelligence and policy priorities based on Ascendis’ internal knowledge and expertise.
- Ensure exemplary behavior, leadership, ethics and transparency within the company, with Health Authorities and other external stakeholders.
- Conduct comprehensive research on policy issues and analyze relevant data.
- Develop policy proposals and recommendations for governmental and non-governmental organizations.
- Collaborate with stakeholders to gather input and build consensus on regulatory policy initiatives.
- Monitor legislative developments and provide updates on relevant regulatory policy changes.
- Prepare detailed reports, briefing notes, and presentations on regulatory policy matters.
- Advise senior management and other decision-makers and stakeholders on policy options and implications.
- Evaluate the impact of existing policies and suggest necessary adjustments.
- Engage in public consultations and community outreach to gather diverse perspectives on regulatory policy initiatives.
- Coordinate with interdisciplinary teams to ensure regulatory policy coherence and alignment.
- Represent the organization in relevant regulatory meetings, conferences, and public forums.
- Stay informed about current events and emerging trends relevant to policy areas.
Benefits
- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of Pet Insurance and Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account (HSA)
- Flexible Spending Accounts
- Various incentive compensation plans
- Accident, Critical Illness, and Hospital Indemnity Insurance
- Mental Health resources
- Paid leave benefits for new parents
Life at Ascendis Pharma
Thrive Here & What We ValueCollaborative work environment | Opportunities for professional growth and development | Flexible work schedule options | Recognition for outstanding performance</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient's lives | Guided by core values of Patients, Science, and Passion | Use TransCon® drug development platform to fulfill mission of developing new therapies | Advancing programs in Endocrinology Rare Disease and Oncology | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets | Seeking passionate People Leader to join growing function | Part of People Leader community with three People Leaders based in Hellerup and Princeton, US | Responsible for well-being and personal development of team members in Denmark | Work closely with Lene Rhein Larsen, People Leader, to continuously improve governance and people processes | Report to Lars Tranberg Pettersson, CIO and work out of our Hellerup office.</s> | Dynamic Workplace for Employees to Grow and Develop Their Skills | TransCon® Drug Development Platform to Fulfill Mission of Developing New and Potentially Best-in-class Therapies to Address Unmet Medical Needs | Exceptional Science, Visionary Leadership, and Skilled and Passionate Colleagues | Collaborative Environment for Skilled, Adaptable, and Highly Resourceful Professionals to Make Their Mark</s> | 1. Entrepreneurial and international company | 2. Short line of command | 3. GCP & GVP regulated environment | 4. Exciting product pipeline | 5. Highly skilled and experienced colleagues</s> | Collaborative culture on an accountability-based team | Unique offerings of Pet Insurance and Legal Insurance | Employee Assistance Program | Employee Discounts | Professional Development | Health Saving Account (HSA) | Flexible Spending Accounts | Various incentive compensation plans | Accident, Critical Illness, and Hospital Indemnity Insurance | Mental Health resources | Paid leave benefits for new parents</s> | 1. Guided by our core values of Patients, Science, and Passion | 2. Use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate bestin-class potential to address unmet medical needs. | 3. Advancing programs in Endocrinology Rare Disease and Oncology. | 4. Collaborating with partners around the world on the development of TransConbased products for other therapeutic areas and markets.</s> | 1. PatientCentric Approach | 2. ScienceDriven Innovation | 3. Passionate Team Members | 4. Collaborative Environment | 5. Dynamic Role</s> | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets</s> | Fast-paced environment with cross-functional, global teams | Collaborative, international and informal environment where we challenge and learn from each other</s> | Patient-centric, science-based, performance-driven | Creating an outstanding workplace</s> | Patient-centric approach to drug development | Emphasis on innovation and scientific excellence | Collaborative work environment with opportunities for professional growth | Focus on making a meaningful difference for patients through our innovative TransCon technology platform | Strong commitment to employee well-being and work-life balance</s> | Visionary leadership</s> | Fostering a place where skilled, adaptable, and highly resourceful professionals can truly make their mark | Using TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs | Advancing programs in Endocrinology Rare Disease and Oncology</s> | Dynamic, fast-growing global biopharmaceutical company | Onsite presence in our Palo Alto, CA office 3 times per week or more, as necessary | Travel within the US &/or to our corporate headquarters in Denmark may be necessary | Focuses on exceptional science, visionary leadership, and skilled and passionate colleagues. | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs. | Fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. | Offers dynamic workplace for employees to grow and develop their skills.</s> | Culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.</s> | Dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States | Providing strategic leadership to ensure the successful design and execution of non-clinical and clinical trials as well as Life Cycle Management Strategies | Engaging closely with internal peers and externally stakeholders such as the FDA, EMA, and other key regulatory bodies | Formulating strategies, enhancing performance, implementing relevant policies, and providing key insights that enable the organization to operate collaboratively and proactively.</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France | Applying innovative TransCon technology platform to build a leading, fully integrated biopharmaceutical company | Diverse pipeline designed to make a meaningful difference for patients | Started launching Endocrinology Rare Disease portfolio globally, in the US, Germany & Austria, with plans for rapid expansion</s> | Passionate about patients and science | Collaborative mindset | Diverse workforce offers a more personal understanding of our customers' needs and concerns | Trusting and appreciative company culture | Value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, and a dynamic, open, and informal working atmosphere | Tremendous opportunity to make an impact | Great team and corporate events | Attractive base salary, sponsored pension scheme (bAV), paid internet, exciting short- and long-term incentives | Structured onboarding program | Tailor-made training and development opportunities embedded in a well-resourced training budget | Direct connection to tram station, parking lots for cars and bikes | Soft drinks and wide variety of snacks | State-of-the-art workplace with iPhone, iPad, and brand-new laptop.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, dynamic working atmosphere, tremendous opportunity to make an impact, great team and corporate events | Structured onboarding program, tailor-made training and development opportunities embedded in a well-resourced training budget | State-of-the-art workplace with iPhone, iPad, and brand-new laptop</s> | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Passionate about training and development — and ready to build something from the ground up | Patients, Science, and Passion core values | Adaptable and highly resourceful professionals can truly make their mark</s> | Fast-paced, cross-functional environment where your coordination skills drive real impact | Innovative treatments for rare diseases while growing commercial experience | Commitment to making a meaningful difference in patient’s lives | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Collaboration with cross-functional, global teams working together to achieve extraordinary results | Informal, open environment where innovation and change are key</s> | Collaborating with cross-functional, global teams working together to achieve extraordinary results | Entrepreneurial, informal, and open environment where innovation and change are key | Passionate about helping Commercial organizations gaining full value of their applications | Committed to making a meaningful difference in patients’ lives</s> | Collaborates with cross-functional scientific affairs team members to ensure that scientific standards are aligned across the organization | Stays current with industry trends, disease state areas, and treatment guidelines that impact training content | Offers employee discounts and mental health resources | Provides paid leave benefits for new parents</s> | Commitment to making a meaningful difference in patient's lives | Key strategic endeavour by Ascendis to expand global footprint in partnership with indirect affiliates across the globe</s> | Collaborating with cross-functional partners to identify and respond to local opportunities and customer needs</s> | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs | Commitment to advancing our Medical Affair’s teams’ scientific knowledge and skills, while making a significant impact in the lives of our patients</s> | Dynamic environment | Opportunity to develop skills and knowledge within the team | Flexible working hours to accommodate study and work</s> | Use TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | Diverse pipeline designed to make a meaningful difference for patients</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patients' lives | Exceptional science, visionary leadership, and skilled and passionate colleagues</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France</s> | TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies</s> | Collaborative environment with strong relationships between internal team and external partners | Inclusive environment for all employees</s>
