Pharmaceutical Clinical Associates, LLC
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Northern,
NJ
Associate Director, Regulatory (STRATEGY)
1. Local or Global Regulatory Leader on global Life Cycle Teams and/or US Product Teams for Projects of moderate complexity (e.g., Phase 2 programs, post-approval stage, etc.)
2. Provides regulatory leadership to a cross-functional global life cycle team (LCT)/US Product team and regulatory subteam (RAFT).
3. Leads the team (LCT/US Product team and RAFT) in developing, implementing and delivering a global regulatory strategy for products which balances time, cost, quality and risk and which meets the needs of patients, prescribers, payers, regulators and Roche Business for an optimal label to commercialize our products.
4. Assures global business objectives are understood and taken into account during regulatory strategy development.
5. Strategizes plans and executes submissions of varying complexity (global dossiers) to global health authorities.
6. Represents Roche as lead interface with health authorities (e.g., FDA). Establishes effective working relationships with health authorities and directs health authority interactions with teams.
7. Establishes and maintains effective working relationships with LCT/RAFT/Business teams. Ensures cross-functional perspectives/expertise is incorporated into regulatory plans prior to decisions being made.
8. Manages decision-making and conflict resolution surrounding regulatory issues within the LCT/US Product Teams and RAFT. Ensure appropriate escalation to management when necessary.
9. Develops regulatory risk management and contingency plans. Communicates plans to management as appropriate.
10. Works with Planning and Finance and functional management to ensure regulatory team has appropriate budget and resources to meet objectives.
11. Chairs Global and/or Local RAFT meetings as appropriate. Motivates and inspires RAFT to meet objectives.
12. Mentors PDR personnel. Networks and shares best practices within function to ensure efficiency and consistency across teams.
13. Analyzes regulatory environment for impact on project/plans and briefs LCT/RAFT/management as appropriate.
14. Leads special regulatory projects/global process initiatives as assigned.
15. Acts as a change agent and role model within PDR by modeling best practices.
16. Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines, and SOPs.
17. May serve as a Clinical Team Leader (CTL) on projects.
18. Provides and receives direct and objective performance feedback on/from LCT, US Product Team and RAFT members.
Experience and Skills:
1. Masters Degree or equivalent
2. 5+ years relevant experience in regulatory affairs
3. Demonstrated expertise/knowledge of core processes: discovery, development, manufacturing and marketing
4. Demonstrated expertise in leading strategic US regulatory development of products.
5. Demonstrated expertise in leading/delivering US and/or global submissions and management of filing review process.
6. Demonstrated command of core competencies listed above.
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: Masters Degree
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Northern, NJ
Northern, New Jersey
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