Regulatory Affairs Manager - Oncology

Ventura County, CA 91320

Posted: 07/13/2018 Category: Pharmaceutical Job Number: 281370-0_1 Salary: $95,000 to $105,000
Regulatory Affairs Manager - Oncology
Location: Ventura County, CA
Industry: Pharma/Biotech
Job Category: Regulatory Affairs
Contact: Ken Kupersmith
[email protected]

Seeking a Regional Regulatory Lead Manager. This position will be located in our offices north of Los Angeles, CA. The Regional Regulatory Manager will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.

The responsibilities of the Regional Regulatory Manager are:
1.To develop and execute regional regulatory strategies and manage effective agency interactions
2.To advise the GRT on regional considerations in developing strategy
3.To ensure the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
4.To ensure that company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products
5.To ensure regulatory compliance, with a focus on patient safety
6.Represent regional regulatory affairs as a member of the GRT, Evidence Generation Team (EGT), Clinical Study Team (CST), Label Working Group (LWG), and/or Regional Teams
7.Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within company's portfolio in compliance with global filing plans and local regulatory requirements
8.Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
9.Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy
10.Manages in the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
11.Supports regional label negotiation activities
12.Obtains and maintains Clinical Trial Authorizations and Marketing

Basic Qualifications:
Doctorate degree
Master's degree and 2 years of Regulatory experience
Bachelor's degree and 4 years of Regulatory experience
Associate's degree and 10 years of Regulatory experience

Preferred Qualifications
1.MS Degree
2.5+ years of Pharmaceutical and/or Biotech experience
3.2+ years of Oncology experience
4.Experience working with policies, procedures and SOP's
5.Knowledge of national legislation and regulations relating to medicinal products
6.Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals
7.Knowledge of drug development
8.Team oriented
9.Strong communication skills - both oral and written
10.Ability to understand and communicate scientific/clinical information
11.Ability to anticipate and prevent potential issues
12.Knowledge of and experience in regional regulatory environment in relevant product area and development stage
13.Understanding of regulatory activities and their touch points
14.Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
15.Cultural awareness and sensitivity to achieve results across both regional country and International borders

Ken Kupersmith
Executive Recruiter

Ken's relationship with his clients and candidates is one of personalized, knowledgeable service. His primary focus is helping companies acquire the top talent they need to grow, and working with candidates throughout their careers to put their skills to their highest and best use.Ken's practice focus is in the recruitment of Medical Affairs, MSLs, Regulatory Affairs and Medical and Scientific Writers.
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