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Regulatory Affairs Associate Director - Brand Job
Date: Nov 20, 2009
Location: Madison, NJ, 07940, USA
Job Title:
Regulatory Affairs Associate Director - Brand
Req #:
5340BR
Job Description:
The Global Regulatory Associate Director handles all regulatory development aspects for prescription brand ("Brand") products. Participates on the product development team to provide regulatory guidance for Pharmaceutical Brand products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for Brand products. May perform due diligence efforts on new product opportunities. Specific
Job Duties:
? Responsible for developing a global product regulatory strategy for Brand pharmaceutical products ? Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development ? Develop a product regulatory timeline aligned to Bausch & Lomb's product development, with key regulatory milestone, and activities for agency filing ? Coordinate with the Labeling Senior Manager for the development of product labels ? Ensure labeling content and product documentation is developed in accordance with regulatory requirements ? Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions ? Coordinate with Global Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities ? Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical Brand products ? Liaise with Bausch & Lomb country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations ? Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections ? Provide regulatory guidance/input to internal product review boards ? Manage assigned personnel Technical Competencies: ? Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations ? Knowledge of domestic and international laws, regulations, and guidance that affect Brand products ? Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses ? Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products ? Ability to influence and partner with cross-functional teams in a global pharmaceutical organization ? Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval ? Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data ? Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks Professional Competencies: ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute and lead a team environment ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Capacity to react quickly and decisively in unexpected situations ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Focused ability to influence operational excellence and performance metrics ? Risk adverse where needed with the ability to identify potential solutions to complex problems
Qualifications
? 8+ years relevant pharmaceutical industry and regulatory experience ? Pharmaceutical brand experience highly preferred ? Bachelors degree in science or health related field ? Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)
Work Location NJ - Madison Relocation Available Yes
Status Full-Time
Regulatory Affairs Associate Director - Brand
Req #:
5340BR
Job Description:
The Global Regulatory Associate Director handles all regulatory development aspects for prescription brand ("Brand") products. Participates on the product development team to provide regulatory guidance for Pharmaceutical Brand products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for Brand products. May perform due diligence efforts on new product opportunities. Specific
Job Duties:
? Responsible for developing a global product regulatory strategy for Brand pharmaceutical products ? Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development ? Develop a product regulatory timeline aligned to Bausch & Lomb's product development, with key regulatory milestone, and activities for agency filing ? Coordinate with the Labeling Senior Manager for the development of product labels ? Ensure labeling content and product documentation is developed in accordance with regulatory requirements ? Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions ? Coordinate with Global Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities ? Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical Brand products ? Liaise with Bausch & Lomb country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations ? Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections ? Provide regulatory guidance/input to internal product review boards ? Manage assigned personnel Technical Competencies: ? Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations ? Knowledge of domestic and international laws, regulations, and guidance that affect Brand products ? Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses ? Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products ? Ability to influence and partner with cross-functional teams in a global pharmaceutical organization ? Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval ? Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data ? Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks Professional Competencies: ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute and lead a team environment ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Capacity to react quickly and decisively in unexpected situations ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Focused ability to influence operational excellence and performance metrics ? Risk adverse where needed with the ability to identify potential solutions to complex problems
Qualifications
? 8+ years relevant pharmaceutical industry and regulatory experience ? Pharmaceutical brand experience highly preferred ? Bachelors degree in science or health related field ? Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)
Work Location NJ - Madison Relocation Available Yes
Status Full-Time
Nearest Major Market: New Jersey
Job Segments: Branding, Management, Manager, Marketing
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