Job Description

As an Associate Director within Development Sciences, you will be responsible for the EU+ regional development strategy in the Alzheimer’s disease area, in alignment with the EU+ business strategy.

Key responsibilities for this role will be:

·       Responsible for defining and implementing EU+ regional regulatory strategies, including filing of regulatory submissions for assigned programs

·       Responsible for leading and/or oversight of the planning, coordination and preparation of regulatory submissions

·       Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks

·       Secure alignment across functions

Direct the organization and preparation of clear and effective submissions

Principal Accountabilities

60%        Responsible for defining/developing and implementing innovative regional regulatory strategies, including filing of all appropriate regulatory submissions e.g. MAAs, PIPs, ODDs. Lead health authority meetings (Scientific advice, PIP clarification, Rapporteur meetings, Pre-submission, oral explanation, SAG etc.).

10%        Identify and assess regulatory risks associated with assigned projects and overall product development. Defining strategies to mitigate risks.

20%        Provide leadership on project teams and subcommittees in all areas of regulatory science. Provide input to Regulatory Senior Management teams and regulatory guidance to company personnel.

5%        Influence key stakeholders in multiple departments at all levels.  Interact with a wide variety of outside contacts (including consultants/ contractors, corporate partners and regulatory agency personnel).

5%        Autonomously represent the company with local and regional regulatory authorities, contractors and corporate partners

Qualifications

•    8-10 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 5 years in Regulatory Sciences.
•    EU regulatory experience managing development programs preferred.
•    Experience in interpretation of regulations, guidelines and policy statements.
•    Experience and knowledge in the preparation of regulatory submissions and involvement in regulatory authority meetings.
 

Minimum Education Requirements

•    BA/BS/University degree required, Life/Health Sciences preferred.