Senior Director, Regulatory Affairs - Job ID: SDRA

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.The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the successful design and execution of non-clinical and clinical trials as well as Life Cycle Management Strategies.

The Sr. Director 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 externally stakeholders such as the FDA, EMA, and other key regulatory bodies. The candidate must not only be adept at formulating and driving strategy, but also be tactically oriented, an exceptional leader with strong people management skills and playing a hands-on role in regulatory.The ideal candidate will have a proven ability to partner effectively with multiple functions, including Clinical development, Research, Product Development, Medical 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 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 position requires a high level of energy, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in the Ascendis Pharma corporate offices in Palo Alto, CA or Princeton, NJ.TAH for assigned product and Head of US RA. Phrase it as you deem fit but make it clear that this is a dual role, somewhere within the Position Summary section of the JD.

Key Responsibilities

Collaborate with Clinical Development, Pharmacovigilance, Biometrics, Core Team Members, Product Management, and Leadership teams to develop and implement the US and global regulatory affairs plan across products
Oversee development and refinement of regulatory policies and procedures and SOPs
Work closely with Commercial, Clinical Development, Medical Affairs, Pharmacovigilance, Biometrics, Core Team Members, Product Management, and Leadership teams in designing and implementing launch strategies and tactics, and life cycle planning with primary focus on the North and South American markets
Provide regulatory assessments of product opportunities and threats
Monitor the competitive environment to sustain expertise in therapeutic area treatment management and new therapies, competitive products and features
Updating status reports and progress summaries to share risks and achievements with Submission team, sub-teams, and senior management

Requirements

Advanced degree (Master’s or PhD) in Life Science with experience working as a RA project lead of BLA and/or NDA filings
Minimum 12 years of documented professional experience at a Regulatory Affairs leadership position within the pharmaceutical or biotechnology industry with focus on biologics, small molecules, or synthetic peptides
Strong understanding of clinical development and how to present clinical data to FDA as well a proven track record in developing regulatory affairs strategies
Preferred experience with a drug device combination products
Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labelling, and developing regulatory strategies
Proven ability to collaborate effectively with multiple functions, including Research, Development, Clinical, Commercial, and Quality across locations and cultures
Ability to travel up to 30-40 days per year domestically and internationally
Broad experience in Regulatory Affairs, working directly with FDA and international agencies with focus on North and South America
Experience with biologics, CMC, Toxicology, Orphan Drugs development, breakthrough and fast track regulatory processes
Strong leadership experience, including mentoring staff and managing regulatory teams across locations
Excellent writing, communication, and presentation skills

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

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>