Head of Pharma Technical Regulatory - Genentech
The Position
As the Head of Pharma Technical Regulatory (PTR) at Genentech, you will lead a global team of about 350 FTEs, reporting directly to the Head of Global Pharma Technical Operations. This leadership role requires strategic direction for regulatory activities across Roche’s global portfolio, ensuring the quality of all Regulatory Applications, including Marketing Authorizations, and driving interactions with global Health Authorities. You will influence regulatory policy and help shape the industry through innovative regulatory approaches, positioning Roche as a leader in technical operations and regulatory affairs.
Key Responsibilities
Regulatory Strategy: Develop and execute global regulatory strategies for all development and marketed products in collaboration with development and product supply teams.
Submission Management: Oversee the content and assembly of all regulatory submissions, ensuring their quality and compliance with global standards.
Health Authority Relations: Lead communication and interactions with global Health Authorities, influencing industry and regulatory practices.
Regulatory Support for Quality Systems: Provide regulatory input for quality system implementation and Pharma Quality System execution.
Leadership and Team Development: Lead and mentor the PTR team, fostering the development of SMEs in regulatory strategy. Ensure efficient resource allocation, talent management, and organizational effectiveness.
Industry Leadership: Ensure Roche is recognized as an industry leader, engaging with both health authorities and industry peers to maintain and elevate Roche’s reputation.
Budget and Resource Management: Oversee and manage the PTR budget, ensuring alignment with organizational goals and efficient use of resources.
Regulatory Compliance: Maintain compliance with all relevant permits and licenses, ensuring consistency between regulatory requirements and technical operations.
Cross-Functional Collaboration: Work with internal and external partners, including PDR, DRA, and PT, to execute regulatory strategies and achieve business objectives.
Organizational Alignment: Ensure the PTR team’s structure and goals align with broader organizational objectives and stakeholder needs.
Who You Are
Education: PhD in a relevant technical area.
Experience: 15+ years in Regulatory Affairs, Quality, Process Development, or Manufacturing within the biopharmaceutical industry.
Leadership Experience: Proven senior leadership experience within the biotechnology or pharmaceutical sectors, with a strong track record of elevating organizational performance.
Interpersonal Skills: Ability to lead and influence diverse, global teams, navigate complex, matrixed environments, and gain alignment across different functional areas.
Change Management: Demonstrated ability to drive change within an organization, fostering a culture of positive transformation while maintaining company values.
Customer Focus: Strong ability to communicate effectively with a wide range of stakeholders, ensuring that customer and business needs are prioritized.
Talent Development: Proven ability to cultivate and align top talent, ensuring teams are strategically positioned to meet business goals.
Equal Opportunity Employer
Genentech is an equal opportunity employer, committed to creating a diverse and inclusive workplace. We provide equal employment opportunities regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.
Accommodation for Applicants
If you have a disability and require accommodations for the application process, please contact us through the provided form for assistance.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
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Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
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Zaventem |Bosnia and Herzegovina :
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Victoria | Remote - Middle East | Manipal | Green Way | Melbourne | McFarland | Lousiana | Castlebar | Bishop | Remote | Riga | French | Remote - Africa | Lenexa | Remote, USA | Springville | Remote - South America (Latin Americal) | Slovakia | Tulsa | Ireland | Leinster | Minnesota | Belgium | Hungary | Hammond | Remote - Europe | Faridabad | Switzerland | Blue Bell | Medan | Thailand | Zaragoza | Bountiful | Nairobi | Texas | Xzagreb |Bucharest :
Bucharest |Makkah :
Khulais | Rabigh | Najran | Riyadh | Jeddah | King Abdullah Economic City |Nišava District :
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