Pharmaceuticals, biopharmaceuticals, medical devices and cosmetics industries in the country are faced with the dual dilemma to access skilled and experienced regulatory personnel.

“The regulatory department is a vital cog in the wheel for companies engaged in the business of pharmaceuticals, biopharmaceuticals, medical devices and cosmetics. Skilled and experienced regulatory affairs personnel are hard to find and are in high demand,” said Dr. Bobby George, vice president & head, regulatory affairs, Reliance Life Sciences Pvt. Ltd.

The role of regulatory affairs personnel is functionally necessary and therefore their presence in a company is indispensable. For a beginner, the qualifications, skill sets and experience are critical factors to secure a job in regulatory affairs. The industry expects the candidates to be updated on the latest developments, particularly changes in regulations, new guidelines, patent litigations and FDA approvals, he added.

Regulatory affairs is a constantly evolving profession that requires ongoing training. Therefore, pharmaceutical companies in India scout for candidates not just with adequate qualification but those with good communication skills both written and oral along with project management proficiencies. Prior experience in product development, quality control, quality assurance, or clinical trials are looked as positive factors in terms of experience. These professionals besides keeping pace with current regulations across regions, need exposure to training programmes in current good manufacturing practices (GMP), good lab practices (GLP), good clinical practices (GCP) and good distribution practices (GDP). These sessions would give them the advantage to succeed in an intensely competitive environment and climb the career ladder, said George in his presentation on 'Regulatory Sciences: Industry Perspective & Human Resource Need'.

Candidates in pharmacy, clinical research analytical chemistry, pharmacology, and pharmaceutics are preferred depending upon the specialization within regulatory affairs where the vacancy exists. Although a post graduate or a doctorate is not always necessary, these qualifications can be beneficial to build his expert status and also to grow up the career ladder, he noted.

Regulatory affairs personnel in a pharma/biopharma company helps to ensure that product development, manufacturing and marketing practices meet or exceed regulatory requirements. Their strategic inputs are crucial to develop safe and effective drugs, medical devices and cosmetics. Their role encompasses a variety of disciplines and job responsibilities, which begins during the product development and continues into the commercial phase. Therefore, comprehending and disseminating information about regulations & guidelines, reviewing and collating data besides timely coordinating with related groups internally constitutes one of the critical roles of regulatory affairs group. This is because there should be no compromise on quality and safety of the drug being manufactured, emphasized George.

“Industry expectations from the candidate for regulatory affairs position revolves around having an eye for detail, an ability to put forward the regulatory expectations in the right perspective, at the same time offer solutions to comply with regulatory requirements,” George said.