Regional Regulatory Manager

For our pharma client in Basel we are currently looking for a

REGIONAL REGULATORY MANAGER

Position incumbent has overall regulatory responsibility for the development and market product portfolio in the assigned region to obtain most rapid approvals with competitive labeling and ensure optimal regulatory compliance within region. The successful candidate ensures alignment of the Regulatory staff in the assigned region strategically and operationally to support the objectives of regional business as part of Global Regulatory Affairs.

TASKS

- The Position incumbent has the responsibility to ensure Regulatory Affairs compliance in the region for all Pharma products enabling safe maintenance.
- Actively contributes in the management of the Regulatory Affairs organization to achieve Global Regulatory Affairs objectives
- He/she is responsible for the execution of the organization set up, both from personnel and from process perspectives.
- Coordinates the regulatory strategic input into development and Life Cycle Management plans for Region.
- The Regional Regulatory Manager also represents Global Development in the external environment, particularly with Health Authorities.
- The incumbent anticipates and influences changes in regulations, guidelines, points to consider, etc. that may affect the approval of our new drugs or current marketed drugs
- Actively participates and directs regulatory participation in industry association groups, (ie PhRMA, IFPMA, EFPIA, DIA, RAPS, ICH etc) to create an effective network with key regulatory agency members as well as proactively influencing the direction of regulatory policy
- Directs regulatory compliance activities in the international regions to ensure that existing marketed drugs are in conformance with local government guidelines and regulations

QUALIFICATIONS

- University degree or equivalent in pharmacy, pharmacology, chemistry or the biological sciences, preferably PhD or MD in a relevant area or equivalent.
- 10 years pharmaceutical industry experience including 5 years of global regulatory experience and 3 years managerial experience.
- In-depth knowledge of the regulatory affairs environment and requirements and proven track record of successful approvals in several Therapeutic Areas.
- Knowledge of the global development processes and in establishing relations with Health Authorities.
- Ability to communicate within Region organization to ensure clear objectives and action plans within team.
- Ability to communicate with Pharma global/local organizations to gain support, ensure alignment, create transparency and install a collaborative culture.

Start: 02.01.2019
Duration: 12 months
Location: Basel

Are you interested to work in this challenging position? Benjamin Wenk, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)

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