Director Global Regulatory Strategy (Molecular Imaging, Pharmaceuticals)

Bayer Inc.•Whippany, NJ

30d

About The Position

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Director Global Regulatory Strategy (Molecular Imaging, Pharmaceuticals) The position is responsible for the development, alignment, and implementation of regulatory strategies to ensure earliest submissions and first cycle approvals with target labels for the assigned development programs of diagnostic drug Molecular Imaging (MI) assets in Radiology on a global basis. Further, the position is in charge for assessing and aligning the probabilities for regulatory success for the assigned development programs. Programs will be diagnostic radiopharmaceuticals as stand-alone and/or theranostic pairs, in a constellation of diagnostic medical device and software assets in the Radiology MI space and therapeutics in the pharmaceutical space, supporting market access requirements in relevant markets.

Requirements

A minimum of a BS degree is required
Experience in biomedical research, including local/global regulatory experience in related TA area
Expert knowledge of the regional HA regulations and advanced knowledge of global regulations. Demonstrated interactions with local health authorities
Excellent communication skills, verbal and written, and strong analytical skills are required; an active communicator
Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence management skills
Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners
Relevant regulatory experience in the development of Radiopharmaceuticals (e.g. diagnostic radiotracers and/or Theranostics) will be considered
Proven experience with FDA regulatory requirements and ICH GCP guidelines for development (IND submission, FDA formal meetings, etc).

Nice To Haves

Advanced technical degree Ph.D., DVM or Pharm D in life sciences with experience in biomedical research, including local/global regulatory experience in related TA area; or MS degree with 6 years of experience in biomedical activities of which 3-5 years include local/global regulatory experience; or BS degree with 10 years of experience in biomedical activities of which 5-10 years include local/global regulatory experience
Experience interacting with or working for the Center for Drug Evaluation and Research (CDER) and/or the Center for Biologics Evaluation and Research (CBER) is preferred.

Responsibilities

Develops Regulatory Strategy for assigned projects by designing and assessing regulatory strategy options on a regional/global basis (as outlined in the Global Regulatory Plan) in line with the Target Product Profile which is designed for successful regulatory approval and market access for one or multiple treatment indications and/or multiple programs
Actively involved in decision making on all key development questions via an assessment on the probability of regulatory success
Develops the regional/global regulatory project goals from development through life cycle
Represents Global Regulatory Affairs on assigned global Project Teams
Develops submission materials for local and global submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global HA regulations and completeness of submission
Lead a global regulatory team (GRT) and coordinate worldwide regulatory input into the global development plan of assigned projects
Organizes and drives preparations for meetings and teleconferences with local and global HA officials
Conduct regulatory due diligence on potential in-licensing opportunities / may support and contribute to Business Development & Licensing (BD&L) activities
Mentor colleagues and promote knowledge-sharing
Provide regulatory and technical expertise as required for the development and tech transfer of manufacturing methods to external vendors/partners
Support the development of cGLP and cGMP radiopharmaceutical manufacturing processes to enable clinical development activities.