Senior Manager/Director, Emerging Markets
Proclinical is currently recruiting for a Senior Manager / Director of Emerging Markets and Global Regulatory Affairs for a pharmaceutical company located in Jersey City, NJ. Successful candidate will define, develop and lead Emerging Market regulatory strategies to obtain and maintain regulatory clearances/approvals in international markets including emerging markets in Asia-Pacific, South America, Middle East and Africa and ensure compliance with product post-marketing approval requirements.
- Define, develop and lead Emerging Market strategies to obtain and maintain regulatory clearances/approvals in international markets including emerging markets in Asia-Pacific, South America, Middle East and Africa.
- Independently manage, plan and direct all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, post approval reporting obligations and general product life cycle management programs.
- Stay current with regulations/guidance in Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
- Provide regulatory expertise on Emerging Markets for multiple projects including non-clinical and clinical aspects of drug development, registration and/or post-marketing compliance and life cycle management.
- Develop effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company's consultants and Business Partners.
- Evaluate new business development opportunities for Emerging Markets and/or participate on due diligence teams.
- Oversee interactions with Health Authorities in Emerging Markets countries for all programs in defined Therapeutic Area scope. Provide interpretation to the business, Global Product Lead and other key stakeholders;
- Lead or support preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required.
- Represents the company in Emerging Markets in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required.
- Provide leadership and training to direct reports and/or mentors team members, if required, to support scope of project work.
- Partner with the regional market access and RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/Health Agency on value and evidence topics and to support Heath Authority decision making.
Skills and Requirements:
- BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred.
- 5-10 years of directly related regulatory experience is desirable and extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases.
- Thorough understanding of global regulations and guidelines.
- Proven ability to successfully manage major submissions and critical projects to deadlines.
- Strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
- Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in all phases of development for emerging markets as well as leading interaction with Health Authorities.
- Preferred experience in managing multiple filings; or managing multiple programs across therapy areas in closely related development area; global involvement also preferred. Must be able to provide guidance in interpreting regulatory regulations and guidelines. Must be able to formulate global regulatory strategy to achieve competitive and accelerated product approvals.
- Solid understanding and ability to interpret complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy.
- Must be strong overall and able to train/develop staff in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong in working well with others, within global teams and communicating with senior leadership and managing relationships with CROs and/or contractors.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.