International Flavors & Fragrances
Global Regulatory Director
International Flavors & Fragrances, Wilmington, Delaware, us, 19894
Job SummaryTitle: Regulatory Affairs and Product Stewardship (RAPS), Pharmaceutical Solutions (PhS) Director
Pharma Solutions (PhS), an IFF Business, applies expert science to advance market-driven, healthy and sustainable solutions for pharmaceutical, dietary supplement, and chemical industries.
In the Global Regulatory Affairs (GRA) team, we have an opening for a Regulatory Affairs and Product Stewardship (RAPS) PhS director to lead the global regulatory team supporting the PhS business and to drive regulatory activities for our ~$1B Pharmaceutical Solutions portfolio of businesses.
IFF's Pharmaceutical Solutions represent one of the industry’s broadest and most flexible portfolios of oral solid dosage advanced pharmaceutical ingredients and excipients. Our solutions for tablets, capsules, multiparticulates, and suspensions help modern medicine meet consumer demand for better health with a full range of immediate, delayed, and sustained release options; taste masking; enhanced bioavailability for novel advanced pharmaceutical ingredients; and naturally derived vegetarian capsules. IFF's Pharmaceutical Solutions products are not only used in pharmaceutical applications but also in food and industrial applications, including cosmetics.
The IFF Global Regulatory Affairs organization employs more than 300 highly specialized and committed colleagues worldwide and has a footprint in more than 20 countries. Our work environment is truly international, and we offer a dynamic working culture focused on partnership, cross-organizational collaboration, and individual development opportunities.
The role reports to the Pharma Solutions President and is preferably located in the US, but with some flexibility.
Responsibilities / Essential FunctionsThe RAPS PhS director sets the personnel, strategic, and technical direction for the regulatory function in full support of the business needs. This role is responsible for the global PhS regulatory team (ca. 30 reports globally).
The role will be a member of the Pharma leadership team and will be responsible for connecting the regulatory changes and requirements impacting the business into the business activities. The leader will prioritize and drive cross-functional regulatory-driven programs.
This position bears the ultimate accountability for regulatory compliance and product stewardship for the PhS business.
Specific Responsibilities include:
Lead the strategic planning for the regulatory function, in coordination with the strategic plans for business – across all functions.
Lead the regulatory department, including annual goal setting, prioritization, staff assessment and development, training, PMPs, and budget.
Guide and support the existing product portfolio in different applications, with projects, lifecycle management of product registrations worldwide, including opening new markets/applications and introducing existing products into additional countries/jurisdictions.
Active involvement with new projects and new product developments, defining regulatory strategies globally and supporting dossier work on an as-needed basis.
Ensure that relevant risk evaluation and management processes are followed and completed.
Provide and support active customer support on regulatory matters.
Proactively identify, support, and direct global and regional advocacy needs with reference to APIs, excipients, etc.
Coordinate and support interface with competent authorities and trade associations (e.g., IPEC, …) to understand regulatory issues of direct impact to the use of IFF's Pharmaceutical Solutions products in finished products in relevant applications.
Provide regulatory updates and interpretations to internal teams and senior management about global regulatory requirements, guidelines, and trends affecting pharmaceutical excipients, food ingredients, and dietary supplements.
Active translator of regulatory issues to, and interface with R&D, Commercial, and Marketing functions to define optimal regulatory pathways aligned with business plans, development opportunities, and R&D objectives.
Active interpreter of regulatory issues and regulation changes to interface with business functions, including R&D, Commercial & Marketing, Operations, Quality, and Engineering, to define and execute course of actions needed.
Support and coordinate relevant dossiers (e.g., DMF, CEP, GRAS, national) for approval.
Coordinate scientific work to support risk assessment (testing program).
External Focus
Expected to spend up to 10-25% of travel time supporting business customer interactions, trade associations, or interacting with government officials.
Preferred Experience & Qualifications
Extensive knowledge and experience of the global and/or regional regulatory landscape for PhS actives, excipients, and finished products and its applications is mandatory.
Regulatory experience with dietary supplement and chemical industries is a plus.
Demonstrated broad regulatory expertise to represent PhS with customers, within trade associations, and authorities.
Proven ability to manage large amounts of information and ability to make both tactical and strategic decisions.
Minimum MSc degree (preferred PhD degree) in Pharmaceutical Science or Regulatory Science.
15+ years of Regulatory Affairs work experience in the Pharmaceutical Industry mainly focused on pharma products.
Demonstrated analytical, conceptual, and strategic thinking.
Excellent oral, written, and presentation skills to inform and influence a broad range of internal and external stakeholders.
Managerial skills, with experience in leading and developing regulatory affairs teams.
Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving regulatory challenges.
Proven strong leadership, decision-making, and interpersonal skills.
Very good organization and strong project management competencies.
Proven strong negotiation skills with health agencies.
Strong influencer and collaborator with interdisciplinary teams.
We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.
Visit
IFF.com/careers/workplace-diversity-and-inclusion
to learn more.
#J-18808-Ljbffr
Pharma Solutions (PhS), an IFF Business, applies expert science to advance market-driven, healthy and sustainable solutions for pharmaceutical, dietary supplement, and chemical industries.
In the Global Regulatory Affairs (GRA) team, we have an opening for a Regulatory Affairs and Product Stewardship (RAPS) PhS director to lead the global regulatory team supporting the PhS business and to drive regulatory activities for our ~$1B Pharmaceutical Solutions portfolio of businesses.
IFF's Pharmaceutical Solutions represent one of the industry’s broadest and most flexible portfolios of oral solid dosage advanced pharmaceutical ingredients and excipients. Our solutions for tablets, capsules, multiparticulates, and suspensions help modern medicine meet consumer demand for better health with a full range of immediate, delayed, and sustained release options; taste masking; enhanced bioavailability for novel advanced pharmaceutical ingredients; and naturally derived vegetarian capsules. IFF's Pharmaceutical Solutions products are not only used in pharmaceutical applications but also in food and industrial applications, including cosmetics.
The IFF Global Regulatory Affairs organization employs more than 300 highly specialized and committed colleagues worldwide and has a footprint in more than 20 countries. Our work environment is truly international, and we offer a dynamic working culture focused on partnership, cross-organizational collaboration, and individual development opportunities.
The role reports to the Pharma Solutions President and is preferably located in the US, but with some flexibility.
Responsibilities / Essential FunctionsThe RAPS PhS director sets the personnel, strategic, and technical direction for the regulatory function in full support of the business needs. This role is responsible for the global PhS regulatory team (ca. 30 reports globally).
The role will be a member of the Pharma leadership team and will be responsible for connecting the regulatory changes and requirements impacting the business into the business activities. The leader will prioritize and drive cross-functional regulatory-driven programs.
This position bears the ultimate accountability for regulatory compliance and product stewardship for the PhS business.
Specific Responsibilities include:
Lead the strategic planning for the regulatory function, in coordination with the strategic plans for business – across all functions.
Lead the regulatory department, including annual goal setting, prioritization, staff assessment and development, training, PMPs, and budget.
Guide and support the existing product portfolio in different applications, with projects, lifecycle management of product registrations worldwide, including opening new markets/applications and introducing existing products into additional countries/jurisdictions.
Active involvement with new projects and new product developments, defining regulatory strategies globally and supporting dossier work on an as-needed basis.
Ensure that relevant risk evaluation and management processes are followed and completed.
Provide and support active customer support on regulatory matters.
Proactively identify, support, and direct global and regional advocacy needs with reference to APIs, excipients, etc.
Coordinate and support interface with competent authorities and trade associations (e.g., IPEC, …) to understand regulatory issues of direct impact to the use of IFF's Pharmaceutical Solutions products in finished products in relevant applications.
Provide regulatory updates and interpretations to internal teams and senior management about global regulatory requirements, guidelines, and trends affecting pharmaceutical excipients, food ingredients, and dietary supplements.
Active translator of regulatory issues to, and interface with R&D, Commercial, and Marketing functions to define optimal regulatory pathways aligned with business plans, development opportunities, and R&D objectives.
Active interpreter of regulatory issues and regulation changes to interface with business functions, including R&D, Commercial & Marketing, Operations, Quality, and Engineering, to define and execute course of actions needed.
Support and coordinate relevant dossiers (e.g., DMF, CEP, GRAS, national) for approval.
Coordinate scientific work to support risk assessment (testing program).
External Focus
Expected to spend up to 10-25% of travel time supporting business customer interactions, trade associations, or interacting with government officials.
Preferred Experience & Qualifications
Extensive knowledge and experience of the global and/or regional regulatory landscape for PhS actives, excipients, and finished products and its applications is mandatory.
Regulatory experience with dietary supplement and chemical industries is a plus.
Demonstrated broad regulatory expertise to represent PhS with customers, within trade associations, and authorities.
Proven ability to manage large amounts of information and ability to make both tactical and strategic decisions.
Minimum MSc degree (preferred PhD degree) in Pharmaceutical Science or Regulatory Science.
15+ years of Regulatory Affairs work experience in the Pharmaceutical Industry mainly focused on pharma products.
Demonstrated analytical, conceptual, and strategic thinking.
Excellent oral, written, and presentation skills to inform and influence a broad range of internal and external stakeholders.
Managerial skills, with experience in leading and developing regulatory affairs teams.
Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving regulatory challenges.
Proven strong leadership, decision-making, and interpersonal skills.
Very good organization and strong project management competencies.
Proven strong negotiation skills with health agencies.
Strong influencer and collaborator with interdisciplinary teams.
We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.
Visit
IFF.com/careers/workplace-diversity-and-inclusion
to learn more.
#J-18808-Ljbffr